Z-1069-2014 Class II Terminated
FDA device recall Z-1069-2014 was initiated by Terumo Cardiovascular Systems Corporation on Dec 12, 2013 and is designated Class II. Reason for recall: Sterility of medical devices intended for use in surgical procedures may be compromised. The recall status is terminated (terminated Jul 28, 2015). Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 5, 2014
- Initiation Date
- Dec 12, 2013
- Termination Date
- Jul 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
Reason for Recall
Sterility of medical devices intended for use in surgical procedures may be compromised.
Distribution Pattern
USA Nationwide Distribution in the state of LA, NJ, and NY.
Code Information
Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1069-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026