—#184703

Product

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

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 Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018

Why it was recalled

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An URGENT MEDICAL DEVICE ALERT dated 11/7/20 was sent to customers. If you are in possession of the impacted product, it is recommended that all alternative options be explored prior to using this product. This includes determining if nonimpacted FMCRTG, LLC lots are available or using alternative suppliers of liquid acid product. This issue only impacts the list of lots provided- no other lots are affected. At this time, we are working with the FDA to determine appropriate next steps. Please note that we are currently experiencing a disruption in our supply, which may impact our ability to distribute non-impacted product. We apologize for any inconvenience. Please contact Fresenius Medical Care Customer Services team at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery. Please contact our Medical Information team at 1-855-616-2309 to discuss any medical or scientific questions you may have. We will provide updates as soon as we have additional information. The health and safety of our patients continue to be our highest priority. Thank you for your cooperation. An additional URGENT MEDICAL DEVICE ALERT dated 11/14/20 was sent to customers. If you currently have or receive impacted product: 1. It is still recommended that all alternative options be explored prior to using this product. This includes the use of non-impacted product from FMCRTG, LLC or similar products from alternate suppliers. 2. Impacted product that is released by FMCRTG, LLC will be clearly marked with Low Sodium at the case level. 3. Use the attached impacted lot list to clearly identify all impacted product in your facility. 4. Mark or tag all impacted product so that any potential user can distinguish between impacted and non-impacted product. 5. Should your facility need to use an impacted product, you must notify your prescribing physicians that dialysis prescription adjustments may be necessary in order to safely use the impacte

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-11-07
Posted by FDA: 2021-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.