Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
This recall has been terminated (originally issued February 22, 2017).
- Recall Initiated
- January 5, 2015
- Posted
- February 22, 2017
- Terminated
- February 23, 2017
- Recall Number
- Z-1232-2017
- Quantity
- 1463
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
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.
Distribution
The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
Lot / Code Info
Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R
Root Cause
Other
Action Taken
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