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Recall Observatory FDA recall evidence

Device 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,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406

Z-1511-2024

March 26, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94295
Status
Ongoing
Classification
Class II
Quantity
1338 cords
Official record key
device-enforcement:Z-1511-2024

Official wording

Reason: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.

Code information: 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 pattern: Global, US: NY, IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.