Device product

(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.

Z-2082-2021

April 28, 2021

Class II

Product summary

Firm: Fresenius Medical Care Holdings, Inc.
Event: Event 87998
Status: Terminated
Classification: Class II
Quantity: (1) 20 cases (2) 30 cases
Official record key: device-enforcement:Z-2082-2021

Official wording

Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions

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

Distribution pattern: US Distribution to: TX only

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Exposed to freezing temperatures due to refrigerated truck malfunctions