| Date Initiated by Firm |
April 28, 2021 |
| Create Date |
July 16, 2021 |
| Recall Status1 |
Terminated 3 on August 08, 2022 |
| Recall Number |
Z-2084-2021 |
| Recall Event ID |
87998 |
| 510(K)Number |
K192209
|
| Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
|
| Product |
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis. |
| Code Information |
Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597 |
Recalling Firm/
Manufacturer |
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
|
| For Additional Information Contact |
Fresenius Medical Care Customer Service
800-323-5188
|
Manufacturer Reason
for Recall |
Exposed to freezing temperatures due to refrigerated truck malfunctions
|
FDA Determined
Cause 2 |
Environmental control |
| Action |
Fresenius issued telephone script communication on April 28.2021 stating reason for recall, heath risk and action to take:
Tell them you already contacted their Home Therapy Nurse to alert them that you would be calling them.
o The purpose of my call today is that you received a delivery from us on (either Feb 22nd or Feb 23rd).
o The truck you received a delivery from had a temperature malfunction due to the bad storms Texas experienced back in February. This caused the product you were delivered to be exposed to freezing or near freezing temperatures for about 3 hours.
o
o I see you received on .
o (if received any PD SOLUTION/SALINE/or CONCENTRATES):
¿ Explain that the solutions inside their product are not affected and that we have freeze/thaw studies that prove this.
¿ Explain that due to the freezing temperatures, the packaging may become compromised, and they may have seen leaks.
¿ For the other products such as Hand Sanitizer and other ancillary products, again, the product could be compromised according to their packaging requirements listed on their packaging.
o We are giving you the opportunity to return these products if you choose to do so at this time.
o If returning product(s):
o Fill out RGA spreadsheet with customer information including how much product they are returning (include lot# and amount returning).
¿ Driver will pick up returned products on their next scheduled visit.
¿ Fresenius Corrections and Removals Rep: Email Post Market Surveillance to open a complaint against product.
o If not returning product(s):
o Thank them for their time and reiterate to always inspect their packaging for leaks as this is what they are trained to do anyways from their Home Therapies Nurse.
If you have any questions call 781-699-2243 or email: beth.st.germain@fmc-na.com |
| Quantity in Commerce |
(1) 40 cases (2) 3 cases (3) 4 cases |
| Distribution |
US Distribution to: TX only |
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = KPO and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
|
