MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Reported: January 31, 2018 Initiated: December 21, 2017 #Z-0411-2018
Product Description
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 186 units
- Distribution
- US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541. Recalled by Baxter Healthcare Corporation. Units affected: 186 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0411-2018.
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