—#160660

Product

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

FDA product code: FLD — Apparatus, Hemoperfusion, Sorbent
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133807
Affected lot / code info: UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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."

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.

Timeline

Recall initiated: 2017-12-21
Terminated: 2020-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160660. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.