Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
FDA device recall Z-1635-2008 · posted 2008-08-14 · Terminated
Recall details
- Recalling firm
- Integra Pain Management
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 500 kits
- Distribution
- CO
- Date initiated
- 2008-03-18
- Date posted
- 2008-08-14
- Date terminated
- 2008-11-05
- Location
- Salt Lake City, UT
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 |