The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the

FDA device recall Z-2436-2010 · posted 2010-09-19 · Terminated

Recall details

Recalling firm

Gyrus Acmi, Incorporated

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.

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.

Root cause

Packaging process control

Status

Terminated

Product code

GCJ

Quantity affected

2 cases (20 devices)

Distribution

UT, PA, Canada

Date initiated

2010-08-03

Date posted

2010-09-19

Date terminated

2012-08-23

Location

Southborough, MA

Related 510(k) clearances