FDA Enforcement
Class II
Terminated
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Recall: Z-1373-2016
·
Reported April 20, 2016
Enforcement
- Recall Number
- Z-1373-2016
- Event ID
- 73390
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 20, 2016
- Initiation Date
- February 23, 2016
- Classification Date
- April 12, 2016
- Termination Date
- September 25, 2019
- Address
- 45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States
Description
Rotaflow Centrifugal Pump 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.
Code Info
BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.
Distribution
US Nationwide Distribution.
Quantity
72,000 units in total