—#124916

Product

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.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K092789
Affected lot / code info: Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K

Why it was recalled

Sterility of medical devices intended for use in surgical procedures may be compromised.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: USA Nationwide Distribution in the state of LA, NJ, and NY.

Timeline

Recall initiated: 2013-12-12
Posted by FDA: 2014-02-21
Terminated: 2015-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.