NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
FDA Recall Z-2110-2018 · Posted None
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Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKPO
Date Initiated2018-05-02
Date Terminated2020-05-13
Product Quantity1060 cases (4240 bottles)
Reason for Recall
The bottles are mislabeled with an incorrect part number.
Firm Action
Phone calls and Urgent Medical Device Recall notification letters were issued on 5/2/18. Customers were instructed to do the following:
Immediately examine your stock to determine whether you have any NaturaLyte Liquid Acid from the lot listed above.
If any products of this lot is found, discontinue use immediately.
Place all units in a secure, segregated area.
Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product and arrange for replacement product.
Promptly fill out and return the attached reply form.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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