(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG… — Class II medical device recall Z-2082-2021
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2021-07-28, distributed in TX. Exposed to freezing temperatures due to refrigerated truck malfunctions
| Recall number | Z-2082-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2021-04-28 |
| Classified | 2021-07-16 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-08-08 |
| Distributed | TX |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840861101313, 00840861101320, 10840861101310, 10840861101327 |
| Lot numbers | B4MA27140BAG, B5MB24110BAG |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2082-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.