Recalls / —
—#185033
Product
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
- 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
- Lot code: 20NTAC040
Why it was recalled
Bottles Missing Product Label
Root cause (FDA determination)
Packaging change control
Action the firm took
Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Address
- 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-12-17
- Terminated
- 2023-01-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #185033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.