Z-1511-2024 Class II Ongoing
FDA device recall Z-1511-2024 was initiated by Baxter Healthcare Corporation on Mar 26, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1338 cords.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Mar 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1338 cords
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.
Distribution Pattern
Global, US: NY, IL
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1511-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026