FDA Device Recall Z-0005-05: CooperSurgical, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-05.

Recall Res Number

Z-0005-05

Recalling Firm / Manufacturer

CooperSurgical, Inc.

FEI Number

1216677

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-08-17

Date Posted

2004-10-05

Date Terminated

2012-05-10

Product Code

HDB

Event Number

29970

Product Quantity

495 units

Product Description Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047

Reason for Recall Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System

Action Details CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.

Distribution Pattern FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy

Code Information / Serial Numbers Lot Number: 30115

Related Establishments / Registrations

COOPERSURGICAL, INC. Registration: 1216677 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
UTAH MEDICAL PRODUCTS, INC. Registration: 1718873 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
CLINICAL INNOVATIONS, LLC Registration: 1722684 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
MEDELA AG Registration: 3002807523 View Registration
QUANTA SYSTEM, S.P.A. Registration: 3004378299 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
CooperSurgical Distribution B.V. Registration: 3014755376 View Registration
FORTUNE MEDICAL INSTRUMENT CORP. Registration: 8022978 View Registration
KEYMED (Medical & Industrial Equipment) Ltd Registration: 9611174 View Registration

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Medical Device Recall: Z-0005-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer