Recall Record: Class II Recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G,… by Fresenius Medical Care Holdings, Inc.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; -- and the recall number Z-2321-2026. If it matches, stop using or distributing it and contact Fresenius Medical Care Holdings, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Fresenius Medical Care Holdings, Inc. and the affected product is described in FDA's record as: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;. FDA's stated reason for the recall is: Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2321-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Fresenius Kabi USA, LLC’s FDA history

Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Fresenius Medical Care Holdings, Inc. recalled Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;. FDA's record states the reason for recall as: Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the (additional items listed in FDA's full record). The.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;) and recall number Z-2321-2026, then follow Fresenius Medical Care Holdings, Inc.'s recall instructions.

Has Fresenius Medical Care Holdings, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 29 total FDA actions tied to Fresenius Medical Care Holdings, Inc., including 27 recalls and 0 warning letters.

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