Reported Jan 31, 2018 · Terminated
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
- Lot codes and dates
- UDI37332414107728
- Lot Numbers
000002259700000226480000022663000002267100000227210000022767
- Amount recalled
- 186 units
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.
This product could cause temporary or reversible health problems — stop using it.
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