Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
Hospira is voluntarily recalling one lot of Minibore Extension Sets due to a confirmed report of solvent occlusion that may prevent priming and delay therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a voluntary precautionary action for a defect that causes a delay in therapy rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Hospira, Inc. is voluntarily recalling one lot of Minibore Extension Sets, 59 inch with Spin Lock Collar, Non-DEHP, Latex-Free. The affected product is identified by List Number 14699-28 and Lot Number 17-077-NS. A total of 48,050 units were distributed nationwide.
The recall is being conducted due to a confirmed customer report of an occlusion of solvent in the male luer lock. This defect has the potential to prevent the set from being primed for use, which could cause a delay in therapy for patients.
Healthcare facilities and consumers should check their inventory for the specific lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action are provided in the source text beyond identifying the affected lot.
The recalled product
- Product
- Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 48,050
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 (2)
- Product List Number: 14699-28
- Lot Number: 17-077-NS
Distribution
Distributed nationwide across the United States.
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