FDAFDA · Food and drugs·Recall number Z-1373-2016
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Published April 20, 2016 · Recall initiated: February 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- US Nationwide Distribution.
- Lot
- BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.