FDA Medical Device Recalls (openFDA)
Hospira Inc.: 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.
- Recall number
- Z-1479-2014
- Recalling firm
- Hospira Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-02-25
- Posted
- 2014-04-21
- Terminated
- 2016-11-28
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- Hospira sent a URGENT MEDICAL DEVICE RECALL letter dated February 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) check their inventory and immediately quarantine any affected product; 2) complete the attached reply form and return it to the fax number or e-mail address on the form; 3) inform potential users within the direct account's organization of this product of the recall; 4) return affected products to Stericycle using labels provided with the notification; and 5) follow the instructions on the return label for returning products. Additional labels and guidance on returning products can be obtained by calling Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET). If the recalled products were further distributed, the recall notification documents should be forwarded to those accounts. Those accounts can contact Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain a reply form and guidance on the return process.
- Quantity
- 3,893 sets
- Distribution
- US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
- Lot, serial or model codes
- Product List Number: 112410403; Lot Numbers: 280055H, 341005H
- 510(k) numbers
- ["K982159"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28