FDA recall Z-2082-2021

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.

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Distribution

US Distribution to: TX only

Key facts

Status

Terminated

Initiation date

2021-04-28

Report date

2021-07-28

Termination date

2022-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2021