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Fresenius Medical Care Holdings, Inc. Recall 90438

Description: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

Fresenius Medical Care Holdings, Inc. Recall 90438 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1371-2022
Event ID90438
Event DescriptionNATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Product TypeDevices
DistributionNatiowide
Quantity163 cases
Recall ReasonAlternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Device Classification20220720
Device Code InfoUDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31
Center Classification Date20220712
Recall Initiation Date20220531
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Letter
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