FDA Enforcement
Class II
Terminated
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Recall: Z-1961-2021
·
Reported July 7, 2021
Enforcement
- Recall Number
- Z-1961-2021
- 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 TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Reason
There is a potential that the pressure tubing may detach from the blood sampling system
Code Info
Lot # 63479666- Not Marketed within the US
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
290 units