Welch Allyn CP150 Electrocardiograph Recall Due to Battery Fire Risk
Baxter Healthcare is recalling Welch Allyn CP150 Electrocardiographs worldwide due to reports of battery-related fires. The fires occurred when devices used non-approved, third-party aftermarket batteries.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with reports of fire hazard. Fire risk represents a significant safety hazard with potential for serious injury, meeting the Severe criterion.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn CP150 Electrocardiograph due to customer reports of battery-related fires. Investigation determined that affected devices were utilizing third-party, aftermarket batteries that are not approved by Baxter.
The recalled product is distributed nationwide in the United States and worldwide. Approximately 41,739 units are affected, encompassing multiple product codes and UDI-DI identifiers in various language configurations.
Users of affected devices should discontinue use of any non-approved, aftermarket batteries and contact Baxter Healthcare or their local representative for guidance on approved battery options. Consumers with questions should reach out to the manufacturer or contact the FDA for additional information.
The recalled product
- Product
- Welch Allyn CP150 Electrocardiograph:
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- battery-fire
- fire-hazard
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)
- All Serial Numbers. Product Code: CP150-2ES2
- UDI-DI: 00732094192131
- Product Code: CP150-2FR2
- UDI-DI: 00732094192124
- Product Code: CP150-2FR5
- UDI-DI: 00732094192117
- Product Code: CP150-2NL2
- UDI-DI: 00732094192100
- Product Code: CP150-2PT2
- UDI-DI: 00732094192087
- Product Code: CP150-2SV2
- UDI-DI: 00732094192070
- Product Code: CP150-3ENB
- UDI-DI: 00732094179705
- Product Code: CP150-3ESB
- UDI-DI: 00732094179682
- Product Code: CP150-4DE2
- UDI-DI: 00732094192063
- Product Code: CP150-4EN2
- UDI-DI: 00732094179675
Distribution
Distributed nationwide across the United States.
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