RecallRadar

FDA Device recall Z-1479-2014

LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel…

On 2014-04-30 the FDA classified a Class II recall of LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel… by Hospira, citing 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 bur….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1479-2014
ClassificationClass II
Statusterminated
Initiated2014-02-25
Published2014-04-30
Last updated2026-09-13 11:53 UTC
CompanyHospira
DistributionFL, IA, IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA, WA

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.

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.

Identifiers

code_infoProduct List Number: 112410403; Lot Numbers: 280055H, 341005H

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2014%22

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