VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The Virtuo
FDA device recall Z-1069-2014 · posted 2014-02-21 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Sterility of medical devices intended for use in surgical procedures may be compromised.
- Action taken
- Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 26 units
- Distribution
- USA Nationwide Distribution in the state of LA, NJ, and NY.
- Date initiated
- 2013-12-12
- Date posted
- 2014-02-21
- Date terminated
- 2015-07-28
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789) | Terumo Cardiovascular Systems Corp. | 2010-05-12 |