Recall Z-0411-2018 ยท FLD Apparatus, Hemoperfusion, Sorbent
Baxter Healthcare Corporation
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
| Date | Dec 21, 2017 |
| Status | Terminated |
| Reason | 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 | 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 q |
| Quantity | 186 units |
| Distribution | US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT Gambro Renal Products, Inc., Mar 26, 2014 |