FDA Device Recall Z-0035-04: VIASYS Med Systems

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-04.

Recall Res Number

Z-0035-04

Recalling Firm / Manufacturer

VIASYS Med Systems

FEI Number

3011270181

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-09-10

Date Posted

2003-10-15

Date Terminated

2004-03-24

Product Code

CAI

Event Number

27242

Product Quantity

60 units

Product Description Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

Reason for Recall The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.

Action Details VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/10-11/03, informing them of the potential for a blocked exhalation hole in the sideport relief valve cap which may result in excess pressure build-up. The accounts were instructed to check their inventory for the affected catalog numbers and lots numbers, place any found on hold for return to VIASYS, and sub-recall the affected product from their customers.

Distribution Pattern Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.

Code Information / Serial Numbers reorder #BLD-83144-24, lot 11679

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
MERCURY MEDICAL Registration: 1024404 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
BIO-MED DEVICES, INC. Registration: 1218704 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
Covidien LLC Registration: 1282497 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
INTERSURGICAL, INC. Registration: 1319447 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
MEDI-PART,INC. Registration: 1420751 View Registration
MEDLINE INDUSTRIES, LP - SPT Registration: 1423395 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
MEDRON, LLC Registration: 1722746 View Registration
KING SYSTEMS CORPORATION. Registration: 1824226 View Registration
Pulmodyne Inc. Registration: 1832562 View Registration
ASPEN SURGICAL PRODUCTS, INC. Registration: 1836161 View Registration
Allied Medical LLC Registration: 1924066 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
COVIDIEN Registration: 2024500 View Registration
WESTMED, INC. Registration: 2028807 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
Datex-Ohmeda, Inc. Registration: 2112667 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. Registration: 2518157 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
INSTRUMENTATION INDUSTRIES, INCORPORATED Registration: 2518436 View Registration
Keystone Industries Registration: 2523320 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
Covidien Registration: 2936999 View Registration
B & B MEDICAL TECHNOLOGIES, INC. Registration: 2938401 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
UAB INTERSURGICAL Registration: 3001313714 View Registration
BAITELLA AG Registration: 3001415205 View Registration
Suzhou Meccan Import and Export Corp. Registration: 3001650535 View Registration
INTERSURGICAL LTD. Registration: 3002807267 View Registration
Diptech Industries Sdn.Bhd. Registration: 3002905553 View Registration
MANUFACTURA INTEGRADA DEL PACIFICO Registration: 3003449582 View Registration
HSINER CO., LTD. Registration: 3003862188 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
ENTER MEDICAL CORPORATION Registration: 3003902679 View Registration
WELL LEAD MEDICAL CO. LTD Registration: 3003903031 View Registration
VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Registration: 3004050971 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
KUNG SHIN PLASTICS CO., LTD. Registration: 3004116032 View Registration
PRODUCTOS MEDLINE S.A. DE C.V. Registration: 3004122598 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
Heuer International (A division of GST Corporation Limited) Registration: 3005273623 View Registration
GENTEC (SHANGHAI) CORPORATION Registration: 3005347827 View Registration
GENESIS MEDICAL PLASTICS LTD. CO. Registration: 3005543241 View Registration
Westmed Javid de Mexico, S.A. de C.V. Registration: 3005587132 View Registration
MEDLINE INDUSTRIES, LP - Laredo Registration: 3005595283 View Registration
NINGBO SHENGYURUI MEDICAL APPLIANCE CO. Registration: 3005767446 View Registration
SUNMED AP, LTD. Registration: 3005998497 View Registration
FLEXICARE MEDICAL (DONGGUAN) LTD. Registration: 3006061749 View Registration
ASIA CONNECTION CO., LTD. Registration: 3006157842 View Registration
ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD Registration: 3006210673 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. Registration: 3006534321 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
NINGBO BESMED MEDICAL EQUIPMENT CORP. Registration: 3006547005 View Registration
Westmed de Mexico, S.A de C.V Registration: 3006606984 View Registration
SMOOTH-BOR PLASTICS Registration: 3006666710 View Registration
GaleMed (Xiamen) Co., Ltd. Registration: 3006783791 View Registration
AOK Tooling Limited Registration: 3006897516 View Registration
HOSPITAL & HOMECARE IMP. & EXP. CO., LTD Registration: 3006897996 View Registration
HENAN TUOREN MEDICAL DEVICE CO., LTD. Registration: 3006984712 View Registration
SURU INTERNATIONAL PVT LTD Registration: 3007092328 View Registration
HANGZHOU SHANYOU MEDICAL EQUIPMENT CO.,LTD Registration: 3007127332 View Registration
Medline Canada Registration: 3007289408 View Registration
JIANGXI GLANCE MEDICAL EQUIPMENT CO., LTD. Registration: 3007997596 View Registration
SAFEGUARD US OPERATING, LLC Registration: 3008258694 View Registration
LG MEDICAL DESIGN, LLC Registration: 3008294339 View Registration
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Registration: 3008693658 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
GPE MedTech Systeme GmbH Registration: 3008867836 View Registration
Medwell Technology Limited Registration: 3009107690 View Registration
UPS SUPPLY CHAIN SOLUTIONS, INC. Registration: 3009171251 View Registration
Tecme SA Registration: 3009302812 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
SHANDONG JINLAI HUANHAI MEDICAL TECHNOLOGY CO.,LTD Registration: 3010187802 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
SHANGHAI BARON TECHNOLOGIES CO LTD Registration: 3010397428 View Registration
WELL LEAD MEDICAL CO. LTD Registration: 3010400865 View Registration
FOREMOUNT ENTERPRISE CO., LTD. Registration: 3010402691 View Registration
MEDITECH SYSTEMS LIMITED Registration: 3010439239 View Registration
NINGBO BOYA MEDICAL EQUIPMENT CO.,LTD. Registration: 3010515776 View Registration
HAIYAN KANGYUAN MEDICAL INSTRUMENT CO.,LTD. Registration: 3010580321 View Registration
ATLAS MEDICAL PRODUCTS LLC Registration: 3010621964 View Registration
TRI-ANIM HEALTH SERVICES, INC. Registration: 3010683054 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
BREAS MEDICAL, INC. Registration: 3010817335 View Registration
Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
AirLife Finland Oy Registration: 3010838917 View Registration
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD Registration: 3010889742 View Registration
NON-CHANGE ENTERPRISE CO., LTD. Registration: 3010957755 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
FLYING TOOLING ENGINEERING LIMITED Registration: 3011185837 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED Registration: 3011587055 View Registration
Baldus Sedation GmbH & Co. KG Registration: 3011780089 View Registration
Boyd Weiler GmbH & Co. KG Registration: 3011986317 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
MEDAS, INC. Registration: 3012050423 View Registration
NOVEM MEDICAL S. DE R.L. DE C.V. Registration: 3012187635 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
SANICURE BV Registration: 3012494290 View Registration
BLUEPOINT MEDICAL GMBH & CO. KG Registration: 3012834717 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
HANGZHOU FORMED MEDICAL DEVICES CO., LTD. Registration: 3013412170 View Registration
VYAIRE MEDICAL, INC. Registration: 3013421741 View Registration
Excellentcare Medical (Huizhou) Ltd. Registration: 3013507143 View Registration
JINHUA KANGDELI MEDICAL APPLIANCES CO.,LTD Registration: 3013530405 View Registration
Ningbo Great Mountain Medical Instruments Co.,Ltd Registration: 3013550220 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
Jiangxi Yiles Medical Co., Ltd Registration: 3013576541 View Registration
ORANTECH INC. Registration: 3013783488 View Registration
HITEC MEDICAL CO., LTD Registration: 3014208300 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
NINGBO CHIBANDA IMP &EXP CO, LTD Registration: 3014437893 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
Pacific Hospital Supply Co., Ltd Registration: 3014615028 View Registration
JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. Registration: 3015058854 View Registration
IVEMSA S.A. de C.V DIVISION AG INDUSTRIES Registration: 3015134079 View Registration
ZHEJIANG HUANYI STERILIZATION TECHNOLOGY CO., LTD Registration: 3015142721 View Registration
INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD. Registration: 3015168843 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
EXIN MEDICAL TECHNOLOGY COMPANY, LLC Registration: 3015191173 View Registration
GUANGZHOU NUONING MEDICAL SUPPLIES CO.,LTD Registration: 3015495690 View Registration
DONGGUAN RONGRUI-CENTURY SCIENCE&TECHNOLOGY CO., LTD Registration: 3015515504 View Registration
VINCENT HEALTHCARE PRODUCTS LIMITED Registration: 3015537026 View Registration
ALL QUALITY & SERVICES, INC. Registration: 3015907115 View Registration
INVENT MEDICAL CORPORATION Registration: 3016052406 View Registration
EVEREAST MEDICAL PRODUCTS GROUP CO., LTD Registration: 3016195240 View Registration
HENAN YADU INDUSTRIAL CO.,LTD Registration: 3016452400 View Registration
SHAOXING REBORN MEDICAL DEVICES CO.,LTD Registration: 3016458361 View Registration
CIRCUITLIFE LLC Registration: 3016634999 View Registration
CREATE BIOTECH CO., LTD. Registration: 3016734145 View Registration
ZHEJIANG GENE SCIENCE CO., LTD Registration: 3016764932 View Registration
GUANGDONG ECAN MEDICAL CO,LTD Registration: 3017171849 View Registration
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. Registration: 3017178358 View Registration
Flexicare Lanka (Pvt) Ltd Registration: 3017202422 View Registration
SharpMed, LLC Registration: 3017828726 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
MCREAT ( GUANGZHOU ) BIO-TECH CO.,LTD Registration: 3018366470 View Registration
PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. Registration: 3018762668 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
RESVENT MEDICAL TECHNOLOGY CO., LTD. Registration: 3019793765 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
S & Mohr America, S.A. DE C.V. Registration: 3020777588 View Registration
CHANGSHA MAGILL MEDICAL TECHNOLOGY CO., LTD. Registration: 3021010418 View Registration
UAB Intersurgical Registration: 3021039857 View Registration
SUNSET HEALTHCARE SOLUTIONS Warehouse Registration: 3021244152 View Registration
Telesair, Inc. Registration: 3021947238 View Registration
Ambu Mexico Operations S.A. DE C.V. Registration: 3022631687 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
RCI HUDSON DE MEXICO S. DE RL. DE CV. Registration: 3029706818 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
HSINER CO., LTD. Registration: 3031369651 View Registration
INDUSTRIAS GRAYLING DE MEXICO, SA DE C Registration: 3032012299 View Registration
YADU MEDICAL (HENAN) CO., LTD Registration: 3034629649 View Registration
SHENZHEN YIMI CARE TECHNOLOGY CO.,LTD Registration: 3036979319 View Registration
Pharmamed SA. Registration: 3037918935 View Registration
WELBREATH TECHNOLOGY CO.,LTD Registration: 3038195661 View Registration
Respironics Medical Products (Shenzhen) Co., Ltd. Registration: 3038562397 View Registration
ASOMEDICA CO. LTD Registration: 3043619925 View Registration
SUNMED AP, LTD., WAREHOUSE NO. 2 Registration: 3044994756 View Registration
BOEN HEALTHCARE CO., LTD. Registration: 3045058049 View Registration
MAQUET CRITICAL CARE AB Registration: 8010042 View Registration
VBM MEDIZINTECHNIK GMBH Registration: 8010939 View Registration
FLEXICARE MEDICAL LTD. Registration: 8021995 View Registration
GLOBALMED, INC. Registration: 8022265 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
GALEMED CORP. Registration: 8043316 View Registration
ORIDION MEDICAL 1987 LTD. Registration: 8044004 View Registration
PACIFIC HOSPITAL SUPPLY CO. LTD. Registration: 8044099 View Registration
PLAXTRON INDUSTRIAL (M) SDN. BHD. Registration: 8044169 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
Covidien Registration: 9610849 View Registration
O-TWO MEDICAL TECHNOLOGIES, INC. Registration: 9610861 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
NARANG MEDICAL, LTD. Registration: 9613910 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
HEADSTAR MEDICAL PRODUCTS CO., LTD Registration: 9616354 View Registration
VADI Medical Technology Co., Ltd. Registration: 9616445 View Registration
DMC MEDICAL LTD. Registration: 9616679 View Registration
POLY MEDICURE LTD. Registration: 9616991 View Registration
BREAS MEDICAL AB Registration: 9617566 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
Mallinckrodt Dar S.r.l. Registration: 9680661 View Registration
Covidien Registration: 9681384 View Registration
SURJEX Registration: 9681622 View Registration
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. Registration: 9710391 View Registration
Besmed Health Business Corporation Registration: 9710567 View Registration
WESTMED de Mexico, S.A de C.V. Registration: 9710644 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-0035-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer