FDA-Device2018-02-14Class II
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Microline Surgical, Inc.
Hazard
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Sold states
Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.
Affected count
61,769 units
Manufactured in
800 Cummings Ctr Ste 166T, N/A, Beverly, MA, United States
Products
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2018Don't want to check this manually?
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