—#196258

Product

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070177
Affected lot / code info: UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036

Why it was recalled

The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

Root cause (FDA determination)

Error in labeling

Action the firm took

On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.

Recalling firm

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

Distribution

Distribution pattern: Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.

Timeline

Recall initiated: 2022-10-04
Posted by FDA: 2022-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196258. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.