The Recall Desk
HighFDA (Devices)·Z-1511-2024·Announced 2024-04-17

Baxter Power Cords Recalled for Electrical Insulation Non-Compliance

Baxter Healthcare is recalling power cord models globally because the insulation does not meet electrical safety standards, creating a potential risk of electrical shock or fire.

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 recall involving a defective electrical safety component with theoretical risk of electrical shock or fire. No injuries, deaths, or confirmed failures have been reported. Per the rubric, risk-of-harm medical devices without documented incidents score 3 (High).

Plain-English summary

Baxter Healthcare Corporation is recalling certain power cord models because the insulation construction does not meet country-specific and international electrical safety standards. The affected models include units marketed under multiple model numbers: 714682, 716010, 716012, 008-0910-00, 008-0912-00, 4500-402, 4500-404, and 4500-406.

Approximately 1,338 power cords have been distributed globally, with documented distribution in New York and Illinois in the United States. The insulation defect could create a risk of electrical shock or fire in medical devices and equipment that depend on these cords.

Consumers and healthcare facilities currently using these power cords should discontinue use immediately and contact Baxter Healthcare Corporation for replacement cords or further instructions. Customers are encouraged to verify their product model numbers against the recall list and report any incidents to Baxter.

The recalled product

Product
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,E
Manufacturer
Baxter Healthcare Corporation
Hazard
  • electrical-shock
  • fire

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 (16)

  • a) 714682
  • UDI/DI 732094121469
  • b) 716010
  • UDI/DI 732094119916
  • c) 716012
  • UDI/DI 732094119879
  • d) 008-0910-00
  • UDI/DI 732094033113
  • e) 008-0912-00
  • UDI/DI 732094033106
  • f) 4500-402
  • UDI/DI 732094004083
  • g) 4500-404
  • UDI/DI 732094004076
  • h) 4500-406
  • UDI/DI 732094004069

Distribution

Distributed in 2 states:

  • IL
  • NY