HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Reported: April 20, 2016 Initiated: February 23, 2016 #Z-1372-2016
Product Description
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Reason for Recall
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 72,000 units in total
- Distribution
- US Nationwide Distribution.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 72,000 units in total.
Why was this product recalled? ▼
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1372-2016.
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