Z-2087-2021 Class II Terminated
FDA device recall Z-2087-2021 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: 120 Bags.
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
- 120 Bags
Product Description
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution Pattern
US Distribution to: TX only
Code Information
Lot Number: 21ATBC004 UDI: (01)00840861101955