Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the failure of a secondary audio signal in a medical infusion device presents a risk of harm (potential dosing errors or missed alerts) even though no specific injuries are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 2,791 units of the Hospira Symbiq Infusion System. The recall was initiated because the devices' secondary audio signal fails to activate. The Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via various routes of administration, including parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation.
The affected devices were distributed in the United States, including the states of Alabama, California, Connecticut, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas, and Washington. The recall covers specific serial numbers associated with List Numbers 16206 and 16027.
Hospira Inc. is the recalling firm. Users should check their device serial numbers against the provided lists to determine if their unit is affected. No specific consumer instructions or corrective actions are detailed in the source text beyond the identification of the defect.
The recalled product
- Product
- The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 2,791
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 (20)
- *** 1) List Number 16206
- Serial Numbers: 0017234975
- 0017234978
- 0017234979
- 0017234980
- 0017234981
- 0017234982
- 0017234983
- 0017234984
- 0017234985
- 0017234986
- 0017234988
- 0017234991
- 0017234992
- 0017234993
- 0017234994
- 0017234995
- 0017234996
- 0017234997
- 0017234998
Distribution
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