Z-1322-2009

Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell...

Name: Z-1322-2009 Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell...
Creator: Tri-State Hospital Supply Corporation
Published: 2009-01-14
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2009-01-14 / Terminated / root cause: packaging

FDA source

Tri-State Hospital Supply Corporation began a recall of Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT3390 on 2009-01-14. The reason FDA records is "Compromised sterility, as the package seals may be inadequate". 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-1322-2009
Status: Terminated
Initiated: 2009-01-14
Posted: 2009-04-30
Terminated: 2009-12-24
Recalling firm: Centurion Medical Products, LP
Product: Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT3390.
Product code: MCZ Suture Removal Kit
Reason for recall: Compromised sterility, as the package seals may be inadequate.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.
Quantity in commerce: 112
Distribution: Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
Product codes and lots: Lot Number: 2008111750.

Product code MCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)