Z-0411-2018Class II

MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

Name: Z-0411-2018 MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Creator: Baxter Healthcare Corporation
Published: 2017-12-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-12-21 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 on 2017-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Posted: 2018-01-24
Terminated: 2020-08-04
Recalling firm: Baxter Healthcare Corporation
Product: MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Product code: FLD Apparatus, Hemoperfusion, Sorbent
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected], 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.
Product codes and lots: UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code FLD

K133807Class IIMars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitGambro Renal Products, Inc. / cleared 2014-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)