Recall Z-0808-2010 ยท FPA Set, Administration, Intravascular
Hospira Inc.
LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28.
| Date | Feb 22, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. |
| Root cause | Process control |
| Action | Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187. |
| Quantity | 47,904 sets |
| Distribution | Minnesota and Utah |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041550 | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Abbott Laboratories, Jun 30, 2004 |