| Date Initiated by Firm |
November 07, 2020 |
| Date Posted |
January 11, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0823-2021 |
| Recall Event ID |
86855 |
| 510(K)Number |
K070177
|
| Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
|
| Product |
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. |
| Code Information |
Lot Numbers: 20LXAC034 20LXAC069 20NXAC040 |
Recalling Firm/
Manufacturer |
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
|
Manufacturer Reason
for Recall |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
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 |
| Quantity in Commerce |
51 drums |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
|
