Agency classClass IOur severity:Severe FDA (Devices)·Z-1827-2012·Announced 2012-07-04

Fresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis

Fresenius Medical Care is recalling GranuFlo Acid Concentrate due to a risk of alkalosis in patients undergoing hemodialysis.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Risk of Alkalosis with acetate containing dialysis acid concentrates"

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling Fresenius GranuFlo (powder) Acid Concentrate. The product is used for the treatment of acute and chronic renal failure during hemodialysis procedures. The recall involves specific product codes, including OFD1201-3B, OFD1251-3B, and others, and applies to all lots.

The recall is being conducted due to a risk of alkalosis associated with acetate-containing dialysis acid concentrates. The product was distributed nationwide and in the country of Guam.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions.

The recalled product

Product: 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…
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Supplies
Hazard: alkalosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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