—#194417

Product

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

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K192017
Affected lot / code info: UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Natiowide

Timeline

Recall initiated: 2022-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194417. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.