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Fresenius Medical Care Holdings, Inc. Recall 86939

Description: Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc. Recall 86939 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0832-2021
Event ID86939
Event DescriptionNaturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity2246 cases
Recall ReasonThe deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Device Classification20210120
Device Code InfoLot Numbers: 20LXAC086 20LXAC099 20NXAC014 Additional Affected lots as of 3/17/21: 20LXAC061 20LXAC062 20LXAC099 20LXAC086 20NXAC014
Center Classification Date20210111
Recall Initiation Date20201123
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Letter
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