FDA Enforcement
Class II
Terminated
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Recall: Z-1963-2021
·
Reported July 7, 2021
Enforcement
- Recall Number
- Z-1963-2021
- Event ID
- 87993
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Edwards Lifesciences, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 7, 2021
- Initiation Date
- May 26, 2021
- Classification Date
- June 25, 2021
- Termination Date
- December 14, 2023
- Address
- 1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States
Description
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Reason
There is a potential that the pressure tubing may detach from the blood sampling system
Code Info
Lot # 63445142 and 63630816
Distribution
US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Quantity
1,679 units