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Class 2 Device Recall MARS Treatment Kit |
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Date Initiated by Firm |
December 21, 2017 |
Create Date |
January 24, 2018 |
Recall Status1 |
Terminated 3 on August 04, 2020 |
Recall Number |
Z-0411-2018 |
Recall Event ID |
78835 |
510(K)Number |
K133807
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Product Classification |
Apparatus, hemoperfusion, sorbent - Product Code FLD
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Product |
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 |
Code Information |
UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm initiated their recall on 12/21/2017 by letter. The recall notice stated the following actions to be taken by the customers:
"1. Locate and remove all affected product from your facility. The product code
and lot number can be found on the individual MARS Treatment Kit box.
2. Contact Baxter Healthcare Center for Service to arrange for return and credit.
Baxter Healthcare Center for Service can be reached at 888-229-0001
between the hours of 7:00 am and 6:00 pm Central Time, Monday through
Friday. Please have your Baxter 8-digit ship-to account number, product code,
lot number, and quantity of product to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed
Baxter customer reply form and return it to Baxter by faxing it to 224-270-
5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have
any inventory." |
Quantity in Commerce |
186 units |
Distribution |
US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France,
Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FLD and Original Applicant = GAMBRO RENAL PRODUCTS, INC.
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