Recall Z-1523-2012 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15E Product Code: 74257
| Date | May 11, 2012 (initiated Apr 12, 2012) |
| Status | Terminated |
| Reason | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss |
| Root cause | Nonconforming Material/Component |
| Action | Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Serv |
| Quantity | 3 units |
| Distribution | Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada. |
| FDA record | Open on fda.gov |