MARS Treatment Kit, Use only with MARS(R) Monitor 1TC… recallZ-0411-2018 · Baxter Healthcare Corporation · initiated Dec 21, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected], even if you do not have any inventory."
Recall details
- Recall number
- Z-0411-2018
- Status
- Terminated
- Initiated by the company
- Dec 21, 2017
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 186 units
- Product code
- FLD
- FDA submissions
- K133807
- Distribution
- US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
Product description
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Code information (models, lots, serial numbers)
UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MARS TREATMENT KIT TYPE 1116/1 - X-MARS US 800541Gambro AB · Apparatus, Hemoperfusion, Sorbent1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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