Z-2320-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Reason for Recall
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Distribution Pattern
US Nationwide distribution in the states of MA, SC.
Code Information
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254