FDA Device Recall Z-0023-2015: Biomedix, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0023-2015.

Recall Res Number

Z-0023-2015

Recalling Firm / Manufacturer

Biomedix, Inc.

FEI Number

1000115518

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-14

Date Posted

2014-10-06

Date Terminated

2014-11-13

Product Code

FPA

Event Number

69249

Product Quantity

2,928

Product Description Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

Reason for Recall Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

Action Details Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.

Distribution Pattern US Distribution including the states of OH, NC, and TX

Code Information / Serial Numbers Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

Related Establishments / Registrations

NEEDLE SPECIALTY PRODUCTS Registration: 1000112137 View Registration
NP MEDICAL Registration: 1000304305 View Registration
Halkey-Roberts Corporation Registration: 1000324175 View Registration
AngioDynamics, Inc. Registration: 1000523114 View Registration
Arrow International CR, a.s. Registration: 1000563940 View Registration
MEDITOP CORPORATION (M) SDN BHD Registration: 1000587249 View Registration
GOLDEN MAX LLC Registration: 1000595987 View Registration
Cordis US Corp. Registration: 1016427 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
BAXTER HEALTHCARE CORPORATION Registration: 1019003 View Registration
BECTON, DICKINSON & CO., (BD) Registration: 1024879 View Registration
MEDICAL ACTION INDUSTRIES, INC. 306 Registration: 1030451 View Registration
EXELINT INTERNATIONAL, CO. Registration: 1035907 View Registration
ADVANCE MEDICAL DESIGNS, INC. Registration: 1037885 View Registration
COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.) Registration: 1038185 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 Registration: 1047429 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
KAWASUMI LABORATORIES AMERICA, INC. Registration: 1055927 View Registration
NIPRO MEDICAL CORPORATION Registration: 1056186 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
WALL MEDICAL, INC. Registration: 1062381 View Registration
CUSTOM ASSEMBLIES, INC. Registration: 1063382 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
MEDICAL SOLUTIONS, INC. Registration: 1125615 View Registration
INTL. MEDICAL INDUSTRIES Registration: 1217831 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
PRIMROSE MEDICAL, INC. Registration: 1220905 View Registration
DEKA RESEARCH & DEVELOPMENT CORP. Registration: 1220973 View Registration
MULTI-MED, INC. Registration: 1221765 View Registration
Vygon MFG Registration: 1223004 View Registration
Conmed Corporation Registration: 1223925 View Registration
SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
EPIMED INTERNATIONAL, INC. Registration: 1316297 View Registration
ANGIODYNAMICS, INC. Registration: 1319211 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
CSL Behring LLC Registration: 1410248 View Registration
BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration
ARGON MEDICAL DEVICES, INC. Registration: 1417485 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
MEDELA LLC Registration: 1419937 View Registration
DOUGLAS MEDICAL PRODUCTS, INC Registration: 1422078 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
CAREFUSION 2200, INC. Registration: 1423507 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
NORFOLK MEDICAL PRODUCTS, INC. Registration: 1450392 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Command Medical Products, LLC. Registration: 1526611 View Registration
ICU Medical, Inc. Registration: 1526863 View Registration
HEALTH CARE LOGISTICS, INC. Registration: 1530671 View Registration
ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
Epimed International, Inc. Registration: 1643059 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
MedXL Registration: 1644312 View Registration
RETRACTABLE TECHNOLOGIES, INC. Registration: 1647137 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
QUEST MEDICAL, INC. Registration: 1649914 View Registration
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. Registration: 1710034 View Registration
ICU MEDICAL, INC Registration: 1713468 View Registration
IPAX, INC. Registration: 1720734 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
GENESEE BIOMEDICAL, INC. Registration: 1723241 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
Cook Incorporated Registration: 1820334 View Registration
BIOMEDIX WAI Registration: 1833470 View Registration
BECTON DICKINSON AND COMPANY Registration: 1911916 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
MOLDED PRODUCTS INC. Registration: 1932668 View Registration
INNOVATIVE MEDICAL TECHNOLOGIES, INC Registration: 1933913 View Registration
ALLERGAN SALES, LLC Registration: 2011068 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
CODAN US CORP. Registration: 2016945 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
ICU MEDICAL, INC. Registration: 2024064 View Registration
ICU MEDICAL, INC. Registration: 2025816 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Synergy Health AST, LLC Registration: 2030598 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
MEDTRONIC MINIMED Registration: 2032227 View Registration
PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
SHONEY SCIENTIFIC, INC. Registration: 2183650 View Registration
BECTON DICKINSON Registration: 2243072 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
VYGON USA Registration: 2245270 View Registration
GENESISBPS LLC Registration: 2248588 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
INNOVATE MEDICAL, LLC Registration: 2321034 View Registration
SZY HOLDINGS LLC. Registration: 2427500 View Registration
BUSSE HOSPITAL DISPOSABLES Registration: 2433012 View Registration
DIRECTMED, INC. Registration: 2437459 View Registration
MEDICAL COMPONENTS INC Registration: 2518902 View Registration
Bayer Medical Care Inc. Registration: 2520313 View Registration
B. BRAUN MEDICAL INC. Registration: 2521402 View Registration
EMED TECHNOLOGIES CORPORATION Registration: 2523167 View Registration
B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
Baxter Healthcare of Puerto Rico LLC Registration: 2649614 View Registration
Fresenius Vial S.A.S. Registration: 3000240707 View Registration
NIPRO CORPORATION Registration: 3000247873 View Registration
IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration
INNOPEX LIMITED Registration: 3001124136 View Registration
TAPASZTO OPTIC LTD. Registration: 3002296055 View Registration
STERIS SPA Registration: 3002806603 View Registration
YPSOMED AG Registration: 3002806818 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
JMS SINGAPORE PTE. LTD Registration: 3002807350 View Registration
SIPA Registration: 3002808466 View Registration
Dimequip Registration: 3002808467 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
MCGUFF COMPANY, INC. Registration: 3003189845 View Registration
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. Registration: 3003310007 View Registration
Unomedical Devices S.A de C.V Registration: 3003442380 View Registration
NYPRO DR, LLC (Bldg 11) Registration: 3003512059 View Registration
CANADIAN HOSPITAL SPECIALTIES LTD Registration: 3003627840 View Registration
MedSource Labs, LLC Registration: 3003674698 View Registration
Biomerics Alajuela Registration: 3003678543 View Registration
FOREFRONT MEDICAL TECHNOLOGY (PTE) LTD. Registration: 3003700453 View Registration
Baxter Limited Registration: 3003704957 View Registration
PT JMS BATAM Registration: 3003895440 View Registration
MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. Registration: 3003915875 View Registration
JDI ELECTRONICS FACTORY Registration: 3003927385 View Registration
INNOVATIVE MEDICAL MANUFACTURING CO. Registration: 3003974574 View Registration
CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. Registration: 3004099493 View Registration
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. Registration: 3004102031 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
PRODUCTOS MEDLINE S.A. DE C.V. Registration: 3004122598 View Registration
NUO THERAPEUTICS, INC. Registration: 3004140833 View Registration
SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTD Registration: 3004143450 View Registration
NEXUS MEDICAL, LLC Registration: 3004194523 View Registration
DRAGON HEART MEDICAL DEVICES CO., LTD. Registration: 3004215921 View Registration
JUMIN BIO-TECHNOLOGIES, CO., LTD Registration: 3004416208 View Registration
TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration
WENZHOU K.L.F. MEDICAL PLASTICS CO., LTD. Registration: 3004538333 View Registration
FENWAL, INC. Registration: 3004548776 View Registration
VYGON COLOMBIA S.A. Registration: 3004569180 View Registration
DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration
DRAGON HEART MEDICAL, INC. Registration: 3004735647 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
Teleflex Medical OEM LLC Registration: 3005232773 View Registration
MANNKIND CORPORATION Registration: 3005340341 View Registration
COMMAND MEDICAL NICARAGUA SA Registration: 3005382983 View Registration
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. Registration: 3005405146 View Registration
CAIR TUNISIE Registration: 3005458990 View Registration
AMSINO MEDICAL (SHANGHAI) CO., LTD. Registration: 3005515211 View Registration
Forsure Medical Products LLC. Registration: 3005609751 View Registration
AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration
JIANGSU CAINA MEDICAL CO., LTD Registration: 3005670221 View Registration
Parker Industrial S de RL de CV Registration: 3005770916 View Registration
FRESENIUS KABI WARRENDALE Registration: 3005778453 View Registration
SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD. Registration: 3005910889 View Registration
MEDXL INC Registration: 3005934752 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
RyMed Technologies, LLC Registration: 3005951712 View Registration
TOTAL VEIN SYSTEMS Registration: 3005987567 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
SMISSON-CARTLEDGE BIOMEDICAL LLC Registration: 3006158088 View Registration
STERLAB Registration: 3006174295 View Registration
Viant Medical SUZHOU EPZ Co., Ltd Registration: 3006194679 View Registration
Bard Access Systems, Inc. Registration: 3006260740 View Registration
NEOCHILD, LLC Registration: 3006271008 View Registration
Arrow International C.R. a.s. Registration: 3006425876 View Registration
THE JAY GROUP Registration: 3006479639 View Registration
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. Registration: 3006534321 View Registration
JOYKEY INDUSTRIAL (PINGHU) LIMITED Registration: 3006542380 View Registration
Zyno Medical LLC. Registration: 3006575795 View Registration
Ningbo Tianyi Medical Appliance CO., Ltd. Registration: 3006795797 View Registration
Delta Med SpA Registration: 3006846316 View Registration
ELCAM MEDICAL ACAL Registration: 3006891665 View Registration
Perouse Medical Registration: 3006942524 View Registration
HAOLANG TECHNOLOGY (FOSHAN) LIMITED CORPORATION Registration: 3006942602 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
Microtrol Sterilisation Services Pvt. Ltd. Registration: 3007185216 View Registration
Consolidated Medical Equipment Company Registration: 3007305485 View Registration
Flextronics Manufacturing Juarez S. DE R.L. DE C.V. Registration: 3007344957 View Registration
PODO XINGDA (TIANJIN) MEDICAL CO., LTD. Registration: 3007363456 View Registration
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. Registration: 3007392007 View Registration
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. Registration: 3007590959 View Registration
Weihai Jierui Medical Products Co., Ltd. Registration: 3007616112 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
GREINER BIO-ONE GMBH Registration: 3007817041 View Registration
ROBLING MEDICAL, LLC Registration: 3007829657 View Registration
HOSMED INC. Registration: 3007836437 View Registration
IntriCon Corporation VH Registration: 3007939342 View Registration
Sterigenics Shanghai E Beam Ltd. Registration: 3008132411 View Registration
DISENO ELECTRONICO MEXICANO SA DE CV Registration: 3008252904 View Registration
Terumo Medical Canada, Inc. Registration: 3008307705 View Registration
Sterigenics S. de R.L. de C.V. Registration: 3008328679 View Registration
CENTURION MEDICAL PRODUCTS, LP Registration: 3008403546 View Registration
CAIR LGL Registration: 3008448733 View Registration
Grupo American Industries, S.A. De C.V Registration: 3008537309 View Registration
M.V. S.R.L. Registration: 3008588205 View Registration
PARAGON 28 Registration: 3008650117 View Registration
RM Healthcare Products SA de CV Registration: 3008692839 View Registration
QUIPMENT Registration: 3008717264 View Registration
EKLA CORPORATION Registration: 3008733163 View Registration
US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA Registration: 3008782867 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
YANGZHOU WEIDELI TRADING CO., LTD. Registration: 3008808123 View Registration
Clinico Medical Sp. z o.o. Registration: 3008810357 View Registration
COMEPSA LTD Registration: 3009328501 View Registration
Optum Distribution Center, LLC Registration: 3009456923 View Registration
ADVANCE TECHNOLOGY LTD Registration: 3009515470 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Yukon Medical, LLC Registration: 3009631669 View Registration
STERIPACK USA (LIMITED) LLC Registration: 3009656988 View Registration
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD Registration: 3009742443 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
Gemtier Medical (Shanghai) Inc. Registration: 3009746425 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
MAGNOLIA MEDICAL TECHNOLOGIES, INC. Registration: 3009976527 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
OMNI MANUFACTURING SERVICES S. A. DE C. V. Registration: 3010047442 View Registration
Emsere, Inc. Registration: 3010082909 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD Registration: 3010149039 View Registration
PROVIDENCE ENTERPRISE LIMITED Registration: 3010162782 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Eitan Medical LTD Registration: 3010293992 View Registration
EMSERE BV Registration: 3010381606 View Registration
METIER MEDICAL (USA) LLC Registration: 3010405396 View Registration
SIAM STERI SERVICES CO., LTD Registration: 3010413216 View Registration
SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
PROMISEMED HANGZHOU MEDITECH CO.,LTD. Registration: 3010515547 View Registration
PRO-TECH Design & Mfg, Inc. Registration: 3010531069 View Registration
ATLAS MEDICAL PRODUCTS LLC Registration: 3010621964 View Registration
BiometerPlus USA, Inc. Registration: 3010830834 View Registration
LILMO Ltd Registration: 3010872792 View Registration
HEALTH LINE INTERNATIONAL CORPORATION Registration: 3010882065 View Registration
ECOMED SOLUTIONS, LLC Registration: 3010934635 View Registration
CUSTOM TUBE MANUFACTURING LLC Registration: 3010966701 View Registration
CYDONIA PHARMA SL Registration: 3011088743 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
Vygon Verneuil Registration: 3011237770 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
ZAPALIGN INC. Registration: 3011944170 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
Shandong Ande Healthcare Apparatus Co., Ltd. Registration: 3012039263 View Registration
MEDAS, INC. Registration: 3012050423 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. Registration: 3012116434 View Registration
NOVEM MEDICAL S. DE R.L. DE C.V. Registration: 3012187635 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
InfuSystem Inc. Registration: 3012337868 View Registration
CAREFUSION Registration: 3012410077 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
Epic International (Thailand) Co., Ltd. Registration: 3012429465 View Registration
AMSINO MEDICAL GROUP (HK) COMPANY LIMITED Registration: 3012445205 View Registration
SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD. Registration: 3012461127 View Registration
SANICURE BV Registration: 3012494290 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
SHANGHAI MEKON MEDICAL DEVICES CO., LTD. Registration: 3012552122 View Registration
BD SWITZERLAND SARL Registration: 3012798826 View Registration
SHIPSERVE NEW ZEALAND LIMITED Registration: 3012809732 View Registration
410 MEDICAL INC. Registration: 3012969104 View Registration
BQ PLUS MEDICAL CO.,LTD Registration: 3013023255 View Registration
BD European Distribution Center Registration: 3013055489 View Registration
Arrow International LLC (subsidiary of Teleflex Incorporated) Registration: 3013162291 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
Border Assembly, S. de R.L. de C.V. Registration: 3013234390 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
ICU MEDICAL, INC. Registration: 3013319212 View Registration
MEDSAFETY SOLUTIONS LLC Registration: 3013445787 View Registration
KM Medical Registration: 3013517171 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
KURIN, INC. Registration: 3013696225 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
Isomedix Operations Inc. Registration: 3013820501 View Registration
WEIGAO MEDICAL INTERNATIONAL CO., LTD. Registration: 3014162214 View Registration
Biomerics Cartago Registration: 3014246639 View Registration
Sol-Millennium Medical, Inc. Registration: 3014312726 View Registration
ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD Registration: 3014314985 View Registration
RIGHT WAY MEDICAL LLC Registration: 3014383500 View Registration
U&U MEDICAL TECHNOLOGY CO., LTD Registration: 3014456066 View Registration
Cair LGL Registration: 3014498869 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
HANGZHOU BEST VALLEY MEDICAL TECHNOLOGY CO., LTD Registration: 3014662855 View Registration
Fresenius Kabi USA, LLC Registration: 3014732157 View Registration
HAEMOTRONIC DE MEXICO S DE RL Registration: 3014936217 View Registration
JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. Registration: 3015058854 View Registration
HANTECH MEDICAL DEVICE CO., LTD. Registration: 3015060216 View Registration
ASSET MEDIKAL TASARIM SAN. TIC. A.S. Registration: 3015085713 View Registration
JIANGSU WLD MEDICAL CO., LTD. Registration: 3015140199 View Registration
ZHEJIANG HUANYI STERILIZATION TECHNOLOGY CO., LTD Registration: 3015142721 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
MERRIMACK MANUFACTURING Registration: 3015192982 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
TAM VIET DISTRIBUTION COMPANY LIMITED Registration: 3015276780 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
ANGIODYNAMICS, INC Registration: 3015537049 View Registration
SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED Registration: 3015620563 View Registration
Hindustan Syringes & Medical Devices Ltd. Registration: 3015724078 View Registration
Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration
Medline Industries (NAMIC Division) - Glen Falls Registration: 3015910259 View Registration
Becton Dickinson Pty Ltd Registration: 3015983454 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
CENTERPIECE S. DE R.L DE C.V Registration: 3016096098 View Registration
PICCGUARD, LLC Registration: 3016472589 View Registration
FACE ONLINE STORE LLC Registration: 3016661372 View Registration
HAOLANG MEDICAL USA CORPORATION Registration: 3016727301 View Registration
MILLYARD ADVANCED MEDICAL PRODUCTS LLC Registration: 3016798778 View Registration
AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP Registration: 3016844398 View Registration
SAINT JONES MANAGEMENT LP EOOD Registration: 3016904853 View Registration
Takeda Pharmaceuticals U.S.A., Inc. Registration: 3016938816 View Registration
OUTSOURCING FARM LA, CORP Registration: 3017088037 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
Unileben S.A. de C.V Registration: 3017262697 View Registration
Harsoria Healthcare Pvt. Ltd. (Unit-2) Registration: 3017406698 View Registration
RHINO MEDICAL SUPPLY INC Registration: 3017509841 View Registration
Hartman Medical Group,LLC Registration: 3017567825 View Registration
STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD. Registration: 3017961114 View Registration
ADVANCED PRODUCT SOLUTIONS INC. Registration: 3018071447 View Registration
MPS PHARMA & MEDICAL, INC. Registration: 3018125942 View Registration
INNOVATIVE HEALTH SCIENCES Registration: 3018229072 View Registration
NAM HA VIET NAM TRADING COMPANY LIMITED Registration: 3018507299 View Registration
BETA BIONICS, INC. Registration: 3019004087 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
CODAN US Corporation Registration: 3020417125 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
S & Mohr America, S.A. DE C.V. Registration: 3020777588 View Registration
PROCEDURE PRODUCTS, INC. Registration: 3020778 View Registration
Life Outcomes Javid de Mexico Registration: 3022964615 View Registration
Intelimas Corporation Registration: 3023228837 View Registration
KORU MEDICAL SYSTEMS, INC. Registration: 3024122953 View Registration
TANDEM DIABETES CARE, INC. Registration: 3027327302 View Registration
RCI HUDSON DE MEXICO S. DE RL. DE CV. Registration: 3029706818 View Registration
MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L. Registration: 3029973819 View Registration
GCB MEDICAL LLC Registration: 3030419987 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
PALM MEDICAL INTERNATIONAL BV Registration: 3030626857 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL Registration: 3030989877 View Registration
BMMEDICAL Registration: 3031233007 View Registration
BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration
MEDI.PLAN GMBH & CO. KG Registration: 3033536319 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
HUZHOU JUNDA INDUSTRY CO., LTD. Registration: 3034669683 View Registration
GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration
Honduras Kitting, S.A. Registration: 3035642068 View Registration
MAYA MEDICAL TOP TRADE LTD. Registration: 3036773433 View Registration
BQ PLUS MEDICAL CO., LTD. Registration: 3036978618 View Registration
TOC Logistics / SOL-MILLENIUM CANADA, INC. Registration: 3038356900 View Registration
PUREBRAND SLUTIONS LTD Registration: 3041276591 View Registration
NOVAMED CO., LTD. Registration: 3042955949 View Registration
15445361 CANADA INC. Registration: 3043051314 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
TOC Logistics / SOL-MILLENIUM CANADA, INC. Registration: 3044026004 View Registration
Yangzhou Xingwei Medical Technology Co. , LTD Registration: 3044994889 View Registration
TERUMO CORP. Registration: 8010026 View Registration
GREINER BIO-ONE GMBH Registration: 8020040 View Registration
VYGON S A Registration: 8020785 View Registration
MULTIMEDICAL SRL Registration: 8021079 View Registration
INDUSTRIE BORLA, S.P.A. Registration: 8021083 View Registration
UNOMEDICAL A/S Registration: 8021545 View Registration
Canadian Hospital Specialties Ltd. Registration: 8022210 View Registration
BAXTER PRODUCTOS MEDICOS, LTDA. Registration: 8040700 View Registration
Nipro (Thailand) Corporation Limited Registration: 8041145 View Registration
BECTON DICKINSON MEDICAL (SINGAPORE) Registration: 8041187 View Registration
B. BRAUN MELSUNGEN AG Registration: 9610825 View Registration
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. Registration: 9610847 View Registration
TOP CORPORATION Registration: 9610993 View Registration
GO MEDICAL INDUSTRIES PTY. LTD. Registration: 9611004 View Registration
SIMPLIVIA HEALTHCARE LTD. Registration: 9611423 View Registration
NIPRO MEDICAL INDUSTRIES LTD. Registration: 9611446 View Registration
PRODUCTOS PARA EL CUIDADO DE LA SALUD Registration: 9611590 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
FENWAL INTERNATIONAL, INC. Registration: 9612051 View Registration
Baxter Healthcare, S.A. Registration: 9612052 View Registration
Vantive Manufacturing Pte. Ltd. Registration: 9612057 View Registration
ELCAM MEDICAL A.C.A.L. Registration: 9612152 View Registration
B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration
ICU Medical Costa Rica Ltd. Registration: 9615050 View Registration
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD Registration: 9615588 View Registration
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG Registration: 9615817 View Registration
KAWASUMI LABORATORIES (THAILAND) CO., LTD. Registration: 9615908 View Registration
SISTEMAS MEDICOS ALARIS, S.A De C.V. Registration: 9616066 View Registration
DAVOL SURGICAL INNOVATIONS Registration: 9616067 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
Cardinal Health Mexico 244 S de RL de CV Registration: 9616099 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
MERIT MEDICAL IRELAND, LTD Registration: 9616662 View Registration
Takeda Manufacturing Austria AG Registration: 9616848 View Registration
Becton, Dickinson & Company (BD) Registration: 9617032 View Registration
ALLERGAN Registration: 9617229 View Registration
SARSTEDT AG & CO. KG Registration: 9617475 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD. Registration: 9680222 View Registration
CARDIO TECHNICS S.A. DE C.V. Registration: 9680306 View Registration
Avent S. de R.L. de C.V. Registration: 9680425 View Registration
TIANJIN HANACO MEDICAL CO.,LTD. Registration: 9680448 View Registration
HENNIG ENTERPRISES EUROPE S.R.L. Registration: 9680787 View Registration
Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
TERUMO EUROPE N.V. Registration: 9681413 View Registration
Coastline de Mexico SA de CV Registration: 9681572 View Registration
FRESENIUS KABI DEUTSCHLAND GMBH Registration: 9681819 View Registration
KOFU FACTORY OF TERUMO CORP. Registration: 9681835 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0023-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer