Recall Z-1479-2014 ยท FRN Pump, Infusion
Hospira Inc.
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
| Date | Apr 21, 2014 (initiated Feb 25, 2014) |
| Status | Terminated |
| Reason | Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL. |
| Root cause | Mixed-up of materials/components |
| Action | Hospira sent a URGENT MEDICAL DEVICE RECALL letter dated February 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) check their inventory and immediately quarantine any affected product; 2) complete the attached reply form and return it to the fax number or e-mail address on the form; 3) inform potential users within the direct account's organization of this product of the recall; 4) return affected products to Stericycle using labels provided with the notification; and 5) follow the instructions on the r |
| Quantity | 3,893 sets |
| Distribution | US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982159 | ABBOTT PLUM A+ INFUSION PUMP Abbott Laboratories, Jan 12, 1999 |