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

Is my product affected?

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

• UPC 37332414107728

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 186 units of the MARS Treatment Kit (Product Code 800541), which is designed for use only with the MARS Monitor 1TC. The recall was initiated due to customer complaints about leakage in the albumin circuit, caused by inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set. The affected kits were distributed to the United States and 17 other countries, including Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.

The affected MARS Treatment Kits have the UDI 37332414107728 and one of the following lot numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, or 0000022767. The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico. Quantity: 186 units Lot/code info: UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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