Z-1460-2011

Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These...

Name: Z-1460-2011 Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These...
Creator: Centurion Medical Products Corporation
Published: 2011-01-14
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2011-01-14 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes on 2011-01-14. The reason FDA records is "The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1460-2011
Status: Terminated
Initiated: 2011-01-14
Posted: 2011-03-08
Terminated: 2011-06-21
Recalling firm: Centurion Medical Products, LP
Product: Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.
Product code: LRS I.V. Start Kit
Reason for recall: The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: [email protected]. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.
Quantity in commerce: 68056 all kits
Distribution: Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.
Product codes and lots: 2010102550

Product code LRS

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)