The Lumenis VersaCut Tissue Morcellator Product Usage recall: Labeling Error
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal…
Why was The Lumenis VersaCut Tissue Morcellator Product Usage recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
- Product
- The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal…
- Recalling firm
- Lumenis Limited
- 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 Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.
- Recall date
- February 20, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)