FDA Device Recall Z-0031-05: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-05.

Recall Res Number

Z-0031-05

Recalling Firm / Manufacturer

N/A

FEI Number

3005747797

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-08-18

Date Posted

2004-10-22

Date Terminated

2005-01-31

Product Code

HBT

Event Number

30060

Product Quantity

119 units

Product Description Hem-o-lok Endo5 Ligation Applier

Reason for Recall The jaws may break during clip loading or clip application.

Action Details Consignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).

Distribution Pattern Nationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.

Code Information / Serial Numbers Catalog number 544965, Lot 943704, 943705, 954592

Related Establishments / Registrations

HARITEX CORPORATION Registration: 1000175697 View Registration
LEMAITRE VASCULAR, INC. Registration: 1220948 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
ETHICON ENDO-SURGERY, INC. Registration: 1527736 View Registration
WEXLER SURGICAL, INC. Registration: 1646747 View Registration
SONTEC INSTRUMENTS, INC. Registration: 1720747 View Registration
ASPEN SURGICAL PRODUCTS, INC. Registration: 1836161 View Registration
TECOMET, INC. Registration: 2132732 View Registration
GSOURCE, LLC. Registration: 2249529 View Registration
Sklar Corporation Registration: 2431166 View Registration
POST SURGICAL MFG. Registration: 2436906 View Registration
AESCULAP, INC. Registration: 2916714 View Registration
TECHNIMEN SKILLERS Registration: 3001620590 View Registration
PETERS SURGICAL Registration: 3001650400 View Registration
ZEPF MEDICAL INSTRUMENTS GMBH Registration: 3003244954 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
HIVE INTERNATIONAL PVT LTD. Registration: 3003807268 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
PETERS SURGICAL Registration: 3004060107 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
ConMed Corporation Registration: 3004491689 View Registration
SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP. Registration: 3005067367 View Registration
ETHICON ENDO-SURGERY, LLC Registration: 3005075853 View Registration
XINHUA SURGICAL INSTRUMENT CO. LTD. Registration: 3005440795 View Registration
BLACK & BLACK SURGICAL, INC. Registration: 3006142527 View Registration
SURGICON PVT LTD Registration: 3007597038 View Registration
B.Braun Medical (Suzhou) Co,.Ltd Registration: 3008711893 View Registration
NOVO SURGICAL, INC. Registration: 3008770252 View Registration
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD. Registration: 3008843439 View Registration
MEED SKILLS SURGICAL Registration: 3008936260 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
NANOVA BIOMATERIALS INC Registration: 3011430871 View Registration
MIZUHO CORPORATION Registration: 3011547624 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
Avalanche Med Sdn Bhd Registration: 3012587552 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
Integra LifeSciences Production Corporation Registration: 3014334038 View Registration
AMNOTEC INTERNATIONAL MEDICAL GMBH Registration: 3014615697 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
HEINRICH MEDIZINTECHNIK GMBH Registration: 3015972835 View Registration
ENDOMED, LLC Registration: 3016248634 View Registration
ALIRA MEDICAL DEVICES LLC Registration: 3022320321 View Registration
SURGISCAPE Registration: 3022862651 View Registration
CHOOSE SURGICAL INSTRUMENTS Registration: 3029082594 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD Registration: 3030839824 View Registration
MED2B LTD. Registration: 3035708926 View Registration
ACKERMANN INSTRUMENTE GMBH Registration: 8010273 View Registration
GEISTER MEDIZINTECHNIK GMBH Registration: 8010697 View Registration
Industrias Apson S.A de C.V Registration: 8030607 View Registration
S & T AG Registration: 8031015 View Registration
QSA SURGICAL (PVT) LTD. Registration: 8040233 View Registration
Falcon Surgical Co. (Pvt.) Ltd. Registration: 8040278 View Registration
ITM Industria de Tecnologias Medicas LTDA Registration: 8043769 View Registration
AESCULAP AG Registration: 9610612 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
DIMEDA INSTRUMENTE GMBH Registration: 9611283 View Registration
ASANUS MEDIZINTECHNIK GMBH Registration: 9616250 View Registration
MIZUHO Corporation Gosen Factory Registration: 9680242 View Registration
CM INSTRUMENTE GMBH Registration: 9680518 View Registration
REBSTOCK INSTRUMENTS GMBH Registration: 9681161 View Registration
ULTIMATE MEDICAL PRODUCTS LTD. Registration: 9710524 View Registration

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Medical Device Recall: Z-0031-05

Recall Parameters & Description

Related Establishments / Registrations

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