Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2082-2021 — (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 R

U.S. FDA — Device Enforcement · United States · 2021-04-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2082-2021
Date of alert: 2021-04-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Holdings, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840861101313

Reported risk: Exposed to freezing temperatures due to refrigerated truck malfunctions

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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