Recall Z-0795-2013
Lumenis Limited · initiated January 2, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Codes / lots: Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
Reason for recall
Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
FDA-determined cause: Labeling design
Action taken
Lumenis sent an Urgent Safety Advisory Notice letter dated January 2, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the devices with the enclosed labels provided, replace the Operation Manual with the current revised Manual, complete the information requested on the Confirmation Card and return the Confirmation Card using the enclosed pre-paid shipping label by UPS. For question contact VersaCut Morcellator field correction administrator by either Cell: +972-(54)-9599196, Tel: +972-(4)-9599296 or E-mail: VersaCutMorcellator@lumenis.com.
Details
- Recall number
- Z-0795-2013
- Initiated
- January 2, 2013
- Posted by FDA
- February 14, 2013
- Terminated
- May 20, 2013
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 931 units
- Distribution
- Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New…
- Recalling firm
- Lumenis Limited