Z-1959-2021 Class II Terminated
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
- 460 units
Product Description
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
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 #s: 63505216 and 63590087