Recall Z-2059-2016 ยท FPA Set, Administration, Intravascular
Hospira Inc.
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM
| Date | Sep 9, 2013 |
| Status | Terminated |
| Reason | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. |
| Root cause | Device Design |
| Action | Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wi |
| Quantity | 1) 65,904 units; 2) 270,321 units; 3) 32,088 units; 4) 4,944 units; 5) 14,064 units; 6) 503,328 units; 7) 7,560 units |
| Distribution | US (Nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories, Jan 12, 1999 |