Recall Z-1062-2010 ยท FPA Set, Administration, Intravascular
Hospira Inc.
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 161010728, REF16101
| Date | Mar 9, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Root cause | Process control |
| Action | Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187. |
| Quantity | 9,744 sets |
| Distribution | Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates. |
| 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 |