Z-1963-2021 Class II Terminated

Recalled by Edwards Lifesciences, LLC — Irvine, CA

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
1,679 units

Product Description

Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782

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 # 63445142 and 63630816