The Recall Desk
HighFDA (Devices)·Z-0821-2022·Announced 2022-03-30

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.

What this means for you

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
Category
Medical Device — Therapeutic Air Supply
Hazard
  • electrical-shock
  • power-cord-damage

Distribution

Distributed nationwide across the United States.

Related recalls

Same category