Z-1635-2008

Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791

Name: Z-1635-2008 Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
Creator: Integra Pain Management
Published: 2008-03-18
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2008-03-18 / Terminated / root cause: manufacturing process

FDA source

Integra Pain Management began a recall of Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791 on 2008-03-18. The reason FDA records is "Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin". 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-1635-2008
Status: Terminated
Initiated: 2008-03-18
Posted: 2008-08-14
Terminated: 2008-11-05
Recalling firm: Integra Pain Management
Product: Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
Product code: FMF Syringe, Piston
Reason for recall: Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.
Quantity in commerce: 500 kits
Distribution: CO
Product codes and lots: Lot Numbers: W0801021, W801104, W0711154.

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