Z-2436-2010

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

Name: Z-2436-2010 The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing...
Creator: Gyrus Acmi, Incorporated
Published: 2010-08-03
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2010-08-03 / Terminated / root cause: packaging

FDA source

Gyrus Acmi, Incorporated began a recall of The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The... on 2010-08-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2436-2010
Status: Terminated
Initiated: 2010-08-03
Posted: 2010-09-19
Terminated: 2012-08-23
Recalling firm: Gyrus ACMI, Inc.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: lot 186540FC

Product code GCJ

K923945Class IIPleatman Sac Specimen ContainerCabot Medical Corp. / cleared 1993-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)