FDA Enforcement
Class II
Terminated
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.
Recall: Z-2087-2021
·
Reported July 28, 2021
Enforcement
- Recall Number
- Z-2087-2021
- Event ID
- 87998
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 28, 2021
- Initiation Date
- April 28, 2021
- Classification Date
- July 16, 2021
- Termination Date
- August 8, 2022
- Address
- 920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States
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
Exposed to freezing temperatures due to refrigerated truck malfunctions
Code Info
Lot Number: 21ATBC004 UDI: (01)00840861101955
Distribution
US Distribution to: TX only
Quantity
120 Bags