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.
This recall has been terminated (originally issued September 19, 2010).
- Company
- Gyrus Acmi, Incorporated
- Recall Initiated
- August 3, 2010
- Posted
- September 19, 2010
- Terminated
- August 23, 2012
- Recall Number
- Z-2436-2010
- Quantity
- 2 cases (20 devices)
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
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.
Distribution
UT, PA, Canada
Lot / Code Info
lot 186540FC
Root Cause
Packaging process control
Action Taken
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.