Recall Z-1232-2017 ยท MWS Stabilizer, Heart
Terumo Cardiovascular Systems Corporation
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
| Date | Feb 22, 2017 (initiated Jan 5, 2015) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site. |
| Root cause | Other |
| Action | A recall notification is being forwarded to all users and consignees who have received product. The notification of this voluntary recall will be sent to the following consignee in each facility:+ Director of Operating Room Services Proposed Level of Effectiveness Checks: Terumo CVS will verify that 100% of all letters are delivered to affected consignees |
| Quantity | 1463 |
| Distribution | The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.