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

Recall Z-1827-2012 — Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal

U.S. FDA — Device Enforcement · United States · 2012-03-29 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1827-2012
Date of alert: 2012-03-29
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Fresenius Medical Care Holdings, Inc.
Product category: device
Product type: Devices

Reported risk: Risk of Alkalosis with acetate containing dialysis acid concentrates

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

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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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