CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
LifeShield Latex-free HemoSet Burette I.V recalled by Hospira
Hospira is recalling LifeShield Latex-free HemoSet Burette I.V, distributed in 14 states. The recall was initiated on 25 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1479-2014
- FDA event ID
- 67722
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2014
- FDA classified
- 21 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2014 | Recall initiated by company | |
| 21 Apr 2014 | Classified by FDA | +55 days |
| 30 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
FloridaIowaIndianaKansasKentuckyMaineMissouriMontanaPennsylvaniaTennesseeTexasUtahVirginiaWashington
Questions about this recall
Is LifeShield Latex-free HemoSet Burette I.V recalled?
Yes. Hospira recalled LifeShield Latex-free HemoSet Burette I.V on 25 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1479-2014.
Why was it recalled?
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.
Which lots are affected?
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Where was it sold?
US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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