FDA Device recall Z-1126-2014
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA by Hospira, citing several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1126-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-25 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | US |
Product
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
Reason
Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
Identifiers
| code_info | *** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Numb…*** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G |
|---|
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-1126-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.