Recall Z-2058-2016 ยท FPA Set, Administration, Intravascular
Hospira Inc.
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Sit
| 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) 941,982 units; 2) 1,200 units; 3) 4,449,939 units |
| Distribution | US (Nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc., Jan 7, 2011 |