Recall Z-0809-2010 ยท FPA Set, Administration, Intravascular
Hospira Inc.
LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19689-01
| 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 | 1,536 sets |
| Distribution | Minnesota and Utah |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052722 | LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS Hospira, Inc., Nov 2, 2005 |