Z-1232-2017 Class II Terminated
FDA device recall Z-1232-2017 was initiated by Terumo Cardiovascular Systems Corporation on Jan 5, 2015 and is designated Class II. 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… The recall status is terminated (terminated Feb 23, 2017). Affected quantity: 1463.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2017
- Initiation Date
- Jan 5, 2015
- Termination Date
- Feb 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1463
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.
Distribution Pattern
The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1232-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026