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
This recall is currently active, issued May 31, 2022. It was issued by Fresenius Medical Care Holdings, Inc..
- Recall Initiated
- May 31, 2022
- Recall Number
- Z-1371-2022
- Quantity
- 163 cases
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Distribution
Natiowide
Lot / Code Info
UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31
Root Cause
Under Investigation by firm
Action Taken
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.