Hospira Recalls LifeShield Blood Sets Due to Assembly Errors
Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the defect is a manufacturing assembly error rather than a high-risk pathogen or structural failure.
Plain-English summary
Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets and Hospira VENISYSTEMS Blood Bottle Pump Sets. The recall involves three list numbers: 126970465, 127200465, and 046419701. The total quantity of units involved is 69,016.
The recall was initiated because several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. These infusion blood sets are intended for the delivery of fluids, including blood and blood products, from a container to a patient's vascular system.
The affected products were distributed worldwide, including nationwide in the United States and in Canada, Spain, France, Ireland, and Slovenia. Specific lot numbers are listed in the agency's recall notice. Consumers and healthcare facilities should check their inventory for the specific list and lot numbers identified in the official recall notice and contact Hospira Inc. for further instructions.
The recalled product
- 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,
- Manufacturer
- Hospira Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- *** 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
Distribution
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