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Terminated

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

FDA Recall Z-1635-2008 · Posted 2008-08-14

Recalling FirmIntegra Pain Management
Recall StatusTerminated
Product CodeFMF
Date Initiated2008-03-18
Date Terminated2008-11-05
Product Quantity500 kits

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960248GENERAL PROCEDURE KITPhysician Industries, Inc. · 1996-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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