Recall Z-1511-2024— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-03-26. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-26
- Firm location
- Deerfield, IL, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.