Medical Device Air Supply Unit Recalled for Potential Electrical Shock Hazard
Baxter Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.
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: FDA Class II medical device with a serious electrical hazard (shock risk from exposed electrical conductors), but no reported injuries, deaths, or illnesses. The hazard is theoretical but presents a credible risk of harm.
Plain-English summary
The Compella Therapy Air Supply Unit, manufactured by Baxter Healthcare Corporation, is being recalled due to potential damage to the power cord that could expose electrical conductors and create a risk of electrical shock from the mains power supply.
The device has been distributed worldwide, including across the United States and 39 other countries. A total of 6,022 units are affected by this recall.
Consumers and healthcare facilities using this device should immediately discontinue use and contact Baxter Healthcare Corporation for instructions on inspection, repair, or replacement options. The device can be identified using the UDI (Unique Device Identifier): 00887761013803.
The recalled product
- Product
- Compella Therapy Air Supply Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 6,022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation 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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