FDA Device Recall Z-0023-2010: Hospira Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0023-2010.

Recall Res Number

Z-0023-2010

Recalling Firm / Manufacturer

Hospira Inc

FEI Number

2921482

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-08-11

Date Posted

2009-10-06

Date Terminated

2010-11-30

Product Code

FRN

Event Number

52866

Product Quantity

204,999 total

Product Description Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07, 12348-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

Reason for Recall Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Action Details Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.

Distribution Pattern Worldwide Distribution

Code Information / Serial Numbers AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1018470 View Registration
MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
KAWASUMI LABORATORIES AMERICA, INC. Registration: 1055927 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
AMERICAN I.V. PRODUCTS, INC. Registration: 1121996 View Registration
STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
MEDICAL SOLUTIONS, INC. Registration: 1125615 View Registration
HAEMONETICS CORPORATION Registration: 1219343 View Registration
SMITH & NEPHEW INC. Registration: 1219602 View Registration
BELMONT MEDICAL TECHNOLOGIES Registration: 1219702 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
DEKA RESEARCH & DEVELOPMENT CORP. Registration: 1220973 View Registration
PROFESSIONAL CONTRACT STERILIZATION, INC. Registration: 1222313 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
Baxter Healthcare Corporation Registration: 1314492 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration
Sterigenics U.S., LLC Registration: 1420032 View Registration
CAREFUSION 2200, INC. Registration: 1423507 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Command Medical Products, LLC. Registration: 1526611 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
ICU MEDICAL, INC Registration: 1713468 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
ZEVEX, INC. Registration: 1722139 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
Cardinal Health Registration: 1921846 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
CareFusion 303, INC. Registration: 2016493 View Registration
Planet Innovation Products, Inc. Registration: 2022994 View Registration
WELLS JOHNSON CO. Registration: 2024022 View Registration
ICU MEDICAL, INC. Registration: 2024064 View Registration
HK SURGICAL, INC. Registration: 2027804 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Sterigenics U.S., LLC Registration: 2029275 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
West Pharmaceutical Services AZ, Inc. Registration: 2032862 View Registration
Sterigenics U.S., LLC Registration: 2219920 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
RBM SERVICES, LLC. Registration: 2320968 View Registration
E-Z-EM, INC. Registration: 2411512 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
STERITECH, INC. Registration: 2650143 View Registration
WalkMed Technologies, LLC Registration: 3000204189 View Registration
Fresenius Vial S.A.S. Registration: 3000240707 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
B. Braun Avitum AG Registration: 3002879653 View Registration
CANE' S.p.A. Registration: 3003098013 View Registration
SPARTRONICS STRONGSVILLE, INC. Registration: 3003144120 View Registration
CareFusion 303, INC Registration: 3003879246 View Registration
JDI ELECTRONICS FACTORY Registration: 3003927385 View Registration
Bayer Medical Care Inc. Registration: 3004056159 View Registration
MILESTONE SCIENTIFIC, INC. Registration: 3004082685 View Registration
KMI IMI GROUP / DBA: INNOVATIVE MED, INC. Registration: 3004112621 View Registration
ConMed Corporation Registration: 3004491689 View Registration
ANDERSEN CALEDONIA LTD Registration: 3004530184 View Registration
FENWAL, INC. Registration: 3004548776 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
IRADIMED CORPORATION Registration: 3005053560 View Registration
COMMAND MEDICAL NICARAGUA SA Registration: 3005382983 View Registration
Sanmina Registration: 3005627859 View Registration
Orbray (Thailand) Co. Ltd. Registration: 3005700264 View Registration
BO-MER PLASTICS Registration: 3005768810 View Registration
FRESENIUS KABI WARRENDALE Registration: 3005778453 View Registration
SMISSON-CARTLEDGE BIOMEDICAL LLC Registration: 3006158088 View Registration
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. Registration: 3006534321 View Registration
Zyno Medical LLC. Registration: 3006575795 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
IntriCon Corporation VH Registration: 3007939342 View Registration
Moog Costa Rica, SRL Registration: 3008058400 View Registration
Sterigenics Shanghai E Beam Ltd. Registration: 3008132411 View Registration
ELIXIR CORPORATION Registration: 3008513006 View Registration
PRIDE Industries Registration: 3008570882 View Registration
RM Healthcare Products SA de CV Registration: 3008692839 View Registration
QUIPMENT Registration: 3008717264 View Registration
Clinico Medical Sp. z o.o. Registration: 3008810357 View Registration
Cardinal Health Costa Rica, S.A. Registration: 3009211636 View Registration
Optum Distribution Center, LLC Registration: 3009456923 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
BMR Medical Registration: 3009754410 View Registration
Emsere, Inc. Registration: 3010082909 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
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
DONGGUAN HONFIELD PRECISION PARTS CO., LTD Registration: 3010564249 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
ZYNO ELECTRIC & MACHINERY LTD, SHANGHAI Registration: 3011688490 View Registration
CLARITY DESIGN, INC. Registration: 3011883032 View Registration
QUIPMENT INC. Registration: 3012302888 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
InfuSystem Inc. Registration: 3012337868 View Registration
SANICURE BV Registration: 3012494290 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
ICU MEDICAL, INC. Registration: 3013319212 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
MED ONE EQUIPMENT SERVICES, LLC Registration: 3013652261 View Registration
SCPHARMACEUTICALS INC. Registration: 3013722099 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
Fresenius Kabi USA, LLC Registration: 3014732157 View Registration
Baxter Innovations & Business Solutions Pvt. Ltd. Registration: 3015158050 View Registration
MERRIMACK MANUFACTURING Registration: 3015192982 View Registration
TAM VIET DISTRIBUTION COMPANY LIMITED Registration: 3015276780 View Registration
STERISERVICE SP. Z O.O. Registration: 3015972753 View Registration
MEDOVATE LIMITED Registration: 3016509758 View Registration
MILLYARD ADVANCED MEDICAL PRODUCTS LLC Registration: 3016798778 View Registration
STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
JEB TECHNOLOGIES LIMITED Registration: 3017907746 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
INNOVATIVE HEALTH SCIENCES Registration: 3018229072 View Registration
S & Mohr America, S.A. DE C.V. Registration: 3020777588 View Registration
KORU MEDICAL SYSTEMS, INC. Registration: 3024122953 View Registration
Sistemas Medicos Alaris S.A de C.V. Registration: 3024706751 View Registration
MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L. Registration: 3029973819 View Registration
MAYA MEDICAL TOP TRADE LTD. Registration: 3036773433 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS Registration: 3042027705 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
GO MEDICAL INDUSTRIES PTY. LTD. Registration: 9611004 View Registration
Cardinal Health (Kenmex Medical Specialties) Registration: 9612030 View Registration
FENWAL INTERNATIONAL, INC. Registration: 9612051 View Registration
B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration
ICU Medical Costa Rica Ltd. Registration: 9615050 View Registration
KAWASUMI LABORATORIES (THAILAND) CO., LTD. Registration: 9615908 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
Haemonetics Mexico Manufacturing S. de R.L. de C.V. Registration: 9617787 View Registration
Avent S. de R.L. de C.V. Registration: 9680425 View Registration
NOUVAG AG Registration: 9680741 View Registration
HENNIG ENTERPRISES EUROPE S.R.L. Registration: 9680787 View Registration
FRESENIUS KABI DEUTSCHLAND GMBH Registration: 9681819 View Registration
Phillips-Medisize A/S Registration: 9710049 View Registration
UAB VILTECHMEDA Registration: 9710593 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-0023-2010

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer