Recall StatusTerminated
Date Initiated2017-12-21
Date Terminated2020-08-04
Product Quantity186 units
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.
Firm 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."
Root Cause
Nonconforming Material/Component
Distribution Pattern
US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France,
Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.