Recall Z-0809-2010
Hospira Inc. · initiated January 8, 2010
Product
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
Codes / lots: List Number: 19689-01, Lot Number: 81-147-5H.
Reason for recall
There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0809-2010
- Initiated
- January 8, 2010
- Posted by FDA
- February 22, 2010
- Terminated
- July 20, 2011
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 1,536 sets
- Distribution
- Minnesota and Utah
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0808-2010 | LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced…There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery… | 01/08/2010Terminated |