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U.S. Department of Health and Human Services

Class 2 Device Recall Pleatman Sac Tissue Removal System

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 Class 2 Recall
Pleatman Sac Tissue Removal System
see related information
Date Posted September 19, 2010
Recall Status1 Terminated on August 23, 2012
Recall Number Z-2436-2010
Recall Event ID 56626
Premarket Notification
510(K) Number
K923945 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.
Code Information lot 186540FC
Recalling Firm/
Manufacturer
Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough, Massachusetts 01772-2118
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
Manufacturer Reason
for Recall
Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac¿ Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of th
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Gyrus Medical, Inc. of Maple Grove, MN issued an Urgent Medical Device Recall drawing attention to a possible package integrity compromise that could affect the product sterility. USA consignees were contacted via telephone on 8/3/10. The firm directed consignees to inspect their stock to confirm if any of the affected lot of product remains in their possession. Use of remaining affected product should cease immediately. Affected products should be return to Gyrus ACMI. For questions or concerns, consignees should contact the firm at (888) 524-7266.
Quantity in Commerce 2 cases (20 devices)
Distribution UT, PA, Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = CABOT MEDICAL CORP.
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