Z-1749-2020 Class II Ongoing
FDA device recall Z-1749-2020 was initiated by Fresenius Medical Care Holdings, Inc. on March 12, 2020 and is designated Class II. Reason for recall: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine The recall status is ongoing. Affected quantity: 15,342.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,342
Product Description
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
Reason for Recall
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
Distribution Pattern
Nationwide Foreign: Canada, Curaca, Guam
Code Information
All serial numbers