FDA Device Recall Z-0039-05: Medrad Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-05.

Recall Res Number

Z-0039-05

Recalling Firm / Manufacturer

Medrad Inc

FEI Number

2520313

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-10-08

Date Posted

2004-10-22

Date Terminated

2005-01-25

Product Code

DXT

Event Number

30240

Product Quantity

1650 kits

Product Description Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Reason for Recall Sterility can be compromised by a component tearing the outer packaging

Action Details The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.

Distribution Pattern The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.

Code Information / Serial Numbers Lot number 45535 exp 9/2008

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.) Registration: 1038185 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
ATRION MEDICAL PRODUCTS, INC. Registration: 1043729 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Liebel-Flarsheim Company LLC Registration: 1518293 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
ICU Medical, Inc. Registration: 1526863 View Registration
ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 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
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Sterigenics U.S., LLC Registration: 2022435 View Registration
APPLIED MEDICAL RESOURCES CORP. Registration: 2027111 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
ACIST MEDICAL SYSTEMS, INC. Registration: 2134243 View Registration
Bayer HealthCare, LLC Registration: 2243252 View Registration
NORTHEAST MEDICAL SYSTEMS AND DESIGN, LLC Registration: 2249018 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
Bayer Medical Care Inc. Registration: 2520313 View Registration
B. BRAUN MEDICAL INC. Registration: 2521402 View Registration
B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration
Covidien Registration: 2936999 View Registration
Suzhou Meccan Import and Export Corp. Registration: 3001650535 View Registration
BAYER PHARMA, AG Registration: 3002808086 View Registration
Nolato GW Tucson Registration: 3002949731 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
NPA de México S. de R.L. de C.V. Registration: 3003542872 View Registration
HANGZHOU JINCHENG MEDICAL SUPPLIES MANUFACTURE CO., LTD. Registration: 3003561450 View Registration
CANADIAN HOSPITAL SPECIALTIES LTD Registration: 3003627840 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
IMAXEON PTY LTD Registration: 3003786696 View Registration
WUXI YUSHOU MEDICAL APPLIANCES CO., LTD Registration: 3003829571 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. Registration: 3003915875 View Registration
VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Registration: 3004050971 View Registration
Bayer Medical Care Inc. Registration: 3004056159 View Registration
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY) Registration: 3004068971 View Registration
STERIS CORPORATION Registration: 3004080920 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. Registration: 3004727093 View Registration
Bracco Injeneering S.A. Registration: 3004753774 View Registration
Bayer Medical Care Inc. Registration: 3006791331 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
SHENZHEN ANTMED CO. LTD Registration: 3007048453 View Registration
ShanDong WeiGao Group Medical Polymer Co., Ltd Registration: 3007084575 View Registration
ALLWELL MEDICAL CORPORATION Registration: 3007138831 View Registration
Medline Canada Registration: 3007289408 View Registration
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Registration: 3007361214 View Registration
RM Healthcare Products SA de CV Registration: 3008692839 View Registration
CHANGZHOU DSB MEDICAL CO., LTD Registration: 3008850249 View Registration
Applied Medical Distribution Center Registration: 3009051888 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
Applied Medical Europe Registration: 3009763019 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
MULTISOURCE MANUFACTURING LLC Registration: 3010009632 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
Synergy Health Allershausen GmbH Registration: 3010160527 View Registration
Merit Medical Systems, Inc. Registration: 3010665433 View Registration
ECOMED SOLUTIONS, LLC Registration: 3010934635 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
Bayer Medical SRL Registration: 3011334555 View Registration
MULTISOURCE MFG. LLC Registration: 3011604145 View Registration
Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
ACIST EUROPE BV Registration: 3012044688 View Registration
Siemens Healthcare Limited Registration: 3012127758 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
Shenzhen Boon Medical Supply Co., Ltd. Registration: 3012395857 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
JIANGXI BAOERAN BIOMEDICAL SCIENCE & TECHNOLOGY CO.,LTD Registration: 3013529745 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
Isomedix Operations Inc. Registration: 3013820501 View Registration
Biomerics Cartago Registration: 3014246639 View Registration
NEMOTO NORTH AMERICA, INC. Registration: 3014498725 View Registration
Pacific Hospital Supply Co., Ltd Registration: 3014615028 View Registration
UNION MEDICAL SHENZHEN CO., LTD. Registration: 3015009200 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
Medline Industries (NAMIC Division) - Glen Falls Registration: 3015910259 View Registration
CENTERPIECE S. DE R.L DE C.V Registration: 3016096098 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD. Registration: 3020298301 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
BLOCK IMAGING PARTS & SERVICE Registration: 3031503890 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD Registration: 3034544377 View Registration
DONGGUAN MEDJOINT BIOTECH CO., LTD. Registration: 3035858922 View Registration
ANTMED MALAYSIA SDN BHD Registration: 3042190142 View Registration
Canadian Hospital Specialties Ltd. Registration: 8022210 View Registration
MICROTEK DOMINICANA, S.A.S. Registration: 8043817 View Registration
PACIFIC HOSPITAL SUPPLY CO. LTD. Registration: 8044099 View Registration
AESCULAP AG Registration: 9610612 View Registration
Covidien Registration: 9610849 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
NEMOTO KYORINDO CO., LTD. Registration: 9616990 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-0039-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer