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Open, Classified

NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0

FDA Recall Z-1370-2022 · Posted None

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2022-05-31
Product Quantity656 cases

Reason for Recall

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

Firm Action

Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take: These instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department. " Immediately examine your stock to determine whether you have NaturaLyte Liquid Acid concentrate with the part and lot numbers listed below. " Only bottles with sealed for your protection on the bottle cap foil are affected (see picture below). " Remove the affected product from your inventory. " FMCRTG, LLC will contact you regarding product return. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have any further questions.

Root Cause

Under Investigation by firm

Distribution Pattern

Natiowide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020-04-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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