Recall Z-1372-2016— Maquet Cardiovascular Us Sales, Llc
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2016-02-23, terminated 2019-09-25. It names one FDA 510(k) clearance: K102726. Product: HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator. Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-23
- Terminated
- 2019-09-25
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.