Recall Z-3176-2011 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
| Date | Sep 9, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. |
| Root cause | Incorrect or no expiration date |
| Action | Terumo Cardiovascular Systems Corp. sent an "Urgent Medical Device Removal" notice dated August 10, 2011 to all affected customers. The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product. For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST. |
| Quantity | 1,531,440 devices |
| Distribution | Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.