Custom Cardiovascular Procedure Kits recall
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass…
Why was Custom Cardiovascular Procedure Kits recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
- Product
- Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass…
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 163 devices
- Distribution
- Distributed to the states of MO and FL.
- Recall date
- July 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)