Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra Lif
FDA device recall Z-2576-2011 · posted 2011-06-22 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Kits contain protective wipes that may be contaminated with Bacillus cereus.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 40 kits
- Distribution
- UT
- Date initiated
- 2011-05-19
- Date posted
- 2011-06-22
- Date terminated
- 2011-08-01
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL PROCEDURE KIT (K960248) | Physician Industries, Inc. | 1996-04-12 |