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Terminated

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

FDA Recall Z-1232-2017 · Posted 2017-02-22

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeMWS
Date Initiated2015-01-05
Date Terminated2017-02-23
Product Quantity1463

Reason for Recall

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.

Firm 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

Root Cause

Other

Distribution Pattern

The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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