Hospira Recalls Symbiq Infusion Pumps Due to Backup Battery Failure
Hospira is recalling 20,311 Symbiq One Channel Infusion Pumps due to a backup battery failure caused by incorrect component installation on some power supply boards.
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 involves a medical device malfunction (backup battery failure) that could compromise the device's ability to function correctly during power outages, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling 20,311 Symbiq One Channel Infusion Pumps (Product List Number 16026) distributed nationwide and in Canada. The recall addresses a malfunction identified as S205 Backup Battery Failure alarms.
The issue stems from the incorrect installation of components on some Power Supply Controller (PSC) Boards distributed prior to September 2012. On affected pumps, the backup battery power discharges and cannot be recharged. This depletion triggers a visual and audible S205 warning alarm, which is intended to notify the user that the coin cell battery powering the backup buzzer may need charging or replacement.
Healthcare facilities and users should check their Symbiq One Channel Infusion Pumps against the list of affected serial numbers provided in the official recall notice. If a pump is affected, users should follow the instructions provided by Hospira for repair or replacement to ensure the device functions correctly.
The recalled product
- Product
- Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 20,311
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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