Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure
Hospira is recalling Symbiq Two Channel Infusers 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 is classified as FDA Class II, and the hazard involves a medical device malfunction that could affect patient safety, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Hospira Inc. is recalling 15,285 Symbiq Two Channel Infuser medical devices. These prescription infusion pumps are used to administer intravenous fluids. The recall covers units distributed nationwide in the United States and in Canada.
The recall is due to reports of Malfunction S205 Backup Battery Failure alarms. This issue is attributed to 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 to be charged or replaced.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. Affected units should be removed from service and returned to Hospira for repair or replacement.
The recalled product
- Product
- Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 15,285
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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