Z-1828-2015 Class II Terminated
FDA device recall Z-1828-2015 was initiated by Terumo Cardiovascular Systems Corp on May 6, 2015 and is designated Class II. Reason for recall: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote poss… The recall status is terminated (terminated July 27, 2015). Affected quantity: 163 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2015
- Initiation Date
- May 6, 2015
- Termination Date
- July 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 devices
Product Description
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Reason for Recall
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Distribution Pattern
Distributed to the states of MO and FL.
Code Information
Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03