Reported Mar 1, 2017 · Terminated
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315
Is this the product you have?
- Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
- Lot codes and dates
- Catalog Number401-231
- Product DescriptionTitan" Stabilizer Attachment
- Lot Number052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment
- Lot Number
020R024R026R029R030R034R035R037R040048R
- Amount recalled
- 1463
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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