Z-2576-2011

Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO...

Name: Z-2576-2011 Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO...
Creator: Integra LifeSciences Corp.
Published: 2011-05-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-05-19 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley... on 2011-05-19. The reason FDA records is "Kits contain protective wipes that may be contaminated with Bacillus cereus". 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-2576-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-06-22
Terminated: 2011-08-01
Recalling firm: Integra LifeSciences Corporation
Product: Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
Product code: FMF Syringe, Piston
Reason for recall: Kits contain protective wipes that may be contaminated with Bacillus cereus.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210.
Quantity in commerce: 40 kits
Distribution: UT
Product codes and lots: Lot/Serial Number(s): W1101008

Product code FMF

K960248Class IIGeneral Procedure KitPhysician Industries, Inc. / cleared 1996-04-12

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)