Baxter TherMax Blood Warmer Units Recalled for Electrical Safety Non-Compliance
Baxter Healthcare is recalling 504 TherMax Blood Warmer Units because they may not meet electrical safety standards for protective earth connections.
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 with a potential electrical safety hazard (risk of electric shock) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 504 units of the TherMax Blood Warmer Unit. The recall was initiated because the devices may not be in compliance with an electrical safety standard. Specifically, the standard requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
The affected units were distributed nationwide to Georgia and Maryland. International distribution included Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand. The recall covers specific product codes 955630 and 955515, along with a detailed list of serial numbers provided in the official notice.
Healthcare facilities and users should check their inventory against the provided serial numbers. If a unit is affected, it should be removed from service and returned to Baxter Healthcare Corporation according to their instructions.
The recalled product
- Product
- TherMax Blood Warmer Unit
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Blood Warmer
- Hazard
- Affected units
- 504
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)
- Product Code: 955630
- UDI: 00085412639505
- Serial Numbers: 101332
- 101335
- 101358
- 101369
- 101402
- 101403
- 101404
- 101406
- 101415
- 101416
- 101429
- 101430
- 101437
- 101439
- 101440
- 101441
- 101443. Product Code: 955515
- Serial Numbers 100261
Distribution
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