PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 20, 2022 Initiated: May 31, 2022 #Z-1371-2022

Product 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

Reason for Recall

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Details

Units Affected
163 cases
Distribution
Natiowide
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 163 cases.
Why was this product recalled?
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Which agency issued this recall?
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1371-2022.