Recall Z-0542-2007 ยท FPA Set, Administration, Intravascular
Hospira Inc.
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01
| Date | Feb 27, 2007 (initiated Dec 20, 2006) |
| Status | Terminated |
| Reason | The tubing can separate from the set at the filter inlet post. |
| Root cause | Other |
| Action | 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. |
| Quantity | 7,656 sets |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830014 | HEMA - NV TRANS. BLOOD FILTER 100/800 Abbott Laboratories, Jan 17, 1983 |