FDA Device Recall Z-0010-2013: C.R. Bard, Inc., Urological Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2013.

Recall Res Number

Z-0010-2013

Recalling Firm / Manufacturer

C.R. Bard, Inc., Urological Division

FEI Number

1018233

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-09-07

Date Posted

2012-10-04

Date Terminated

2013-03-21

Product Code

KOD

Event Number

63136

Product Quantity

4,032 units

Product Description 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Reason for Recall The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

Action Details An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.

Distribution Pattern Nationwide distribution: USA and Puerto Rico

Code Information / Serial Numbers Catalog # 165808, Lot # NGWA1111

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
CONVATEC LIMITED Registration: 1000317571 View Registration
COOK INCORPORATED Registration: 1000393132 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 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
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
C.R. BARD, INC. Registration: 1313046 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
HOLLISTER INCORPORATED Registration: 1480288 View Registration
BIOMERICS FMI Registration: 1646831 View Registration
Steritec Services, LLC Registration: 1647149 View Registration
NURSE ASSIST, LLC Registration: 1650927 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 1828132 View Registration
BOSMA INDUSTRIES FOR THE BLIND, INC. Registration: 1833700 View Registration
Cardinal Health Registration: 1921846 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Xeridiem Medical Devices Registration: 2025851 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
HOLLISTER, INC. Registration: 2320961 View Registration
Sklar Corporation Registration: 2431166 View Registration
Covidien Registration: 2936999 View Registration
INNOPEX LIMITED Registration: 3001124136 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
WELL LEAD MEDICAL CO. LTD Registration: 3003903031 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 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
STERIS AST CZ s.r.o. Registration: 3004784537 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
DEGANIA MEDICAL DEVICES PVT. LTD. Registration: 3005483737 View Registration
CARDINAL HEALTH SINGAPORE 225 PTE LTD Registration: 3005674464 View Registration
UNOMEDICAL S.R.O. Registration: 3005778470 View Registration
ALLWIN MEDICAL DEVICES, INC. Registration: 3005987240 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
STERLAB Registration: 3006174295 View Registration
INTEGRAL MEDICAL PRODUCTS CO., LTD. Registration: 3006430057 View Registration
SUZHOU JINGLE POLYMER MEDICAL APPARATUS CO., LTD. Registration: 3006536657 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
TELEFLEX MEDICAL Registration: 3007134520 View Registration
Microtrol Sterilisation Services Pvt. Ltd. Registration: 3007185216 View Registration
ROBLING MEDICAL, LLC Registration: 3007829657 View Registration
Hollister Medical India Private Limited Registration: 3008191244 View Registration
Terumo Medical Canada, Inc. Registration: 3008307705 View Registration
HR PHARMACEUTICALS, INC d/b/a HR HealthCare Registration: 3008502431 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
A+ SECURE PACKAGING Registration: 3008816891 View Registration
STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
UPS SUPPLY CHAIN SOLUTIONS, INC. Registration: 3009171251 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration
Microtrol Sterilisation Services Pvt. Ltd. Registration: 3009609358 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
WELL LEAD MEDICAL CO. LTD Registration: 3010400865 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
UROGEN PHARMA LTD. Registration: 3013024191 View Registration
KM Medical Registration: 3013517171 View Registration
MED PRO MEDICAL B.V Registration: 3013530345 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
CLINISUPPLIES (NANJING) CO., LTD Registration: 3014195785 View Registration
Hollister Services BV Registration: 3014404707 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
RHENUS SE & CO. KG Registration: 3014656749 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
HANGZHOU JIMUSHI MEDITECH CO., LTD. Registration: 3016863553 View Registration
GUANGDONG ECAN MEDICAL CO,LTD Registration: 3017171849 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
KHTP STERILISATION SERVICES SDN. BHD. Registration: 3022518300 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
TERUMO CORP. Registration: 8010026 View Registration
FORTUNE MEDICAL INSTRUMENT CORP. Registration: 8022978 View Registration
DEGANIA SILICONE, LTD. Registration: 8030107 View Registration
Teleflex Medical Sdn. Bhd. Registration: 8040412 View Registration
BARD SDN. BHD. Registration: 8040607 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
Covidien Registration: 9610849 View Registration
GO MEDICAL INDUSTRIES PTY. LTD. Registration: 9611004 View Registration
Euroband Bioline LTD. Registration: 9611024 View Registration
PRODUCTOS PARA EL CUIDADO DE LA SALUD Registration: 9611590 View Registration
MEDIQUIP SDN. BHD. Registration: 9611712 View Registration
Cardinal Health (Kenmex Medical Specialties) Registration: 9612030 View Registration
DAVOL SURGICAL INNOVATIONS Registration: 9616067 View Registration
TELEFLEX MEDICAL Registration: 9616683 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
Allwin Medical Devices Pvt. Ltd. Registration: 9617744 View Registration
HENNIG ENTERPRISES EUROPE S.R.L. Registration: 9680787 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
Covidien Registration: 9681384 View Registration
ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 View Registration
SEI Medical S.A. de C.V. Registration: 9710641 View Registration

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Medical Device Recall: Z-0010-2013

Recall Parameters & Description

Related Establishments / Registrations

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