Date Initiated by Firm |
October 04, 2022 |
Date Posted |
November 04, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0181-2023 |
Recall Event ID |
90947 |
510(K)Number |
K070177
|
Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
|
Product |
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. |
Code Information |
UDI-DI: 00840861101610
Lots:
20LTAC076
20PTAC094
21ATAC046
21BTAC082
21CTAC029
21KTAC072
21PTAC023
21STAC094
22DTAC036 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Bld 950 Waltham MA 02451-1521
|
For Additional Information Contact |
Fresenius Medical Care Technical Service 800-227-2572
|
Manufacturer Reason for Recall |
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product.
Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions. |
Quantity in Commerce |
17700 |
Distribution |
Domestic distribution to AL
AZ
CA
DC
FL
GA
HI
IL
IN
MD
MI
MO
MS
NE
NJ
NY
OH
PA
SD
TX
VA
No foreign 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
|