Recalls / —
—#100796
Product
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K960248
- Affected lot / code info
- Lot/Serial Number(s): W1101008
Why it was recalled
Kits contain protective wipes that may be contaminated with Bacillus cereus.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- UT
Timeline
- Recall initiated
- 2011-05-19
- Posted by FDA
- 2011-06-22
- Terminated
- 2011-08-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.