Maquet Cardiovascular Us Sales, Llc recalls HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
- Recall date
- February 23, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1372-2016
- FDA classification
- Class II
- Brand / firm
- Maquet Cardiovascular Us Sales, Llc
- Sold / distributed
- US Nationwide Distribution.
Why it was recalled
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
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