FDA-Device2017-03-01Class II
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Terumo Cardiovascular Systems Corporation
Hazard
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.
Sold states
The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
Affected count
1463
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2017Don't want to check this manually?
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