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Terumo Cardiovascular Systems Corporation recalls Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Recalled March 1, 2017 · FDA recall Z-1232-2017 · Terumo Cardiovascular Systems
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. · FDA Class II
Units
1463
Sold at
The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
Description
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.
Product
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →