Recall Z-1368-2010 ยท FPA Set, Administration, Intravascular
Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback with high-pressure filter and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11963-68.
| Date | Apr 15, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Root cause | Component design/selection |
| Action | Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with th |
| Quantity | 396,588 sets |
| Distribution | Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030002 | LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. Abbott Laboratories, Jan 27, 2003 |