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Terminated

Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.

FDA Recall Z-2575-2011 · Posted 2011-06-22

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeFMF
Date Initiated2011-05-19
Date Terminated2011-08-01
Product Quantity520 kits

Reason for Recall

Kits contain protective wipes that may be contaminated with Bacillus cereus.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

UT

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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