Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
This recall has been terminated (originally issued June 22, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- May 19, 2011
- Posted
- June 22, 2011
- Terminated
- August 1, 2011
- Recall Number
- Z-2575-2011
- Quantity
- 520 kits
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Kits contain protective wipes that may be contaminated with Bacillus cereus.
Distribution
UT
Lot / Code Info
Lot/Serial Number(s): W1009188, W1009261, W1011070, W1101120, W1102014, W1103011
Root Cause
Nonconforming Material/Component
Action Taken
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.