Recall Z-0505-06 ยท FPA Set, Administration, Intravascular
Hospira Inc.
LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
| Date | Feb 8, 2006 (initiated Jan 9, 2006) |
| Status | Terminated |
| Reason | The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market. |
| Root cause | Other |
| Action | Hospira notified all of their customers who purchased these list numbers within the last year via letter dated 1/9/06, informing them of the diversion of the affected lots of product prior to being sterilized and that use of the lots could result in the delivery of fluids through a non-sterile pathway. They requested the accounts to check their stocks of the affected list numbers for the list lot numbers. If any of the lots are found in stock, they were requested to place them in quarantine immediately and call Hospira Customer Care at 1-877-946-7747. |
| Quantity | 48 sets |
| Distribution | The lots were not released or distributed by Hospira |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832755 | INFUSION PUMP & IV SETS #4000 Omni-Glow, Inc., Nov 3, 1983 |