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Recall Observatory FDA recall evidence

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

February 25, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    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.