Recall Z-1232-2017— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2015-01-05, terminated 2017-02-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment. 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..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-05
- Terminated
- 2017-02-23
- Firm location
- Elkton, MD, United States
Product description
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.