Z-1964-2021 Class II Terminated
FDA device recall Z-1964-2021 was initiated by Edwards Lifesciences, LLC on May 26, 2021 and is designated Class II. Reason for recall: There is a potential that the pressure tubing may detach from the blood sampling system The recall status is terminated (terminated December 14, 2023). Affected quantity: 990 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- May 26, 2021
- Termination Date
- December 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 990 units
Product Description
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Reason for Recall
There is a potential that the pressure tubing may detach from the blood sampling system
Distribution Pattern
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
Code Information
Lot # 63438489