Device product
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.
Z-1479-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,893 sets
- Official record key
device-enforcement:Z-1479-2014
Official wording
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.
Code information: Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Distribution pattern: US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
Derived failure modes
-
Unknown
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.