Titan" Stabilizer Attachment and Titan TM 360 recall
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Why was Titan" Stabilizer Attachment and Titan TM 360 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 1463
- Distribution
- The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)