Baxter Recalls MARS Treatment Kits Due to Albumin Circuit Leakage
Baxter Healthcare is recalling 186 MARS Treatment Kits because of a defect in the albumin circuit that causes leakage. The issue stems from an inadequate adhesive connection in the tubing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Baxter Healthcare Corporation is recalling 186 units of the MARS Treatment Kit, Product Code 800541. This product is used exclusively with the MARS(R) Monitor 1TC. The recall is being conducted due to customer complaints regarding leakage in the albumin circuit.
The leakage is caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set, which is a component of the MARS Treatment Kit. The affected lots are 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, and 0000022767. The UDI for the product is 37332414107728.
The affected units were distributed in the US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico. Users should stop using the affected kits and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 186
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI: 37332414107728
- Lot Numbers: 0000022597
- 0000022648
- 0000022663
- 0000022671
- 0000022721
- 0000022767
Distribution
Distribution scope not specified by the agency.
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