Date Initiated by Firm |
August 03, 2010 |
Date Posted |
September 19, 2010 |
Recall Status1 |
Terminated 3 on August 23, 2012 |
Recall Number |
Z-2436-2010 |
Recall Event ID |
56626 |
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 MA 01772-2118
|
For Additional Information Contact |
508-804-2600
|
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 the packaged device.
|
FDA Determined Cause 2 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GCJ and Original Applicant = CABOT MEDICAL CORP.
|