Z-2082-2021 Class II Terminated
FDA device recall Z-2082-2021 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: (1) 20 cases (2) 30 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
- (1) 20 cases (2) 30 cases
Product Description
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution Pattern
US Distribution to: TX only
Code Information
(1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327