LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Conver
FDA device recall Z-0542-2007 · posted 2007-02-27 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The tubing can separate from the set at the filter inlet post.
- Action taken
- Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 7,656 sets
- Distribution
- Nationwide.
- Date initiated
- 2006-12-20
- Date posted
- 2007-02-27
- Date terminated
- 2008-03-24
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMA - NV TRANS. BLOOD FILTER 100/800 (K830014) | Abbott Laboratories | 1983-01-17 |