Z-1479-2014 Class II Terminated
FDA device recall Z-1479-2014 was initiated by Hospira Inc. on Feb 25, 2014 and is designated Class II. 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… The recall status is terminated (terminated Nov 28, 2016). Affected quantity: 3,893 sets.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 30, 2014
- Initiation Date
- Feb 25, 2014
- Termination Date
- Nov 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,893 sets
Product Description
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 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.
Distribution Pattern
US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
Code Information
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1479-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026