Z-2085-2021 Class II Terminated
FDA device recall Z-2085-2021 was initiated by Fresenius Medical Care Holdings, Inc. on April 28, 2021 and is designated Class II. Reason for recall: Exposed to freezing temperatures due to refrigerated truck malfunctions The recall status is terminated (terminated August 8, 2022). Affected quantity: 6 Cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- August 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 Cases
Product Description
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution Pattern
US Distribution to: TX only
Code Information
Lot Number: 20HR08054 UDI: (01)00840861101115