FDA-Device2014-05-28Class II

Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

Microline Surgical
Hazard

Grasper jaw may break when force is applied to the jaw

Sold states
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Affected count
540 units
Manufactured in
50 Dunham Rd, N/A, Beverly, MA, United States
Products
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2014

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