FDA-Device2013-10-02Class II
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Endoplus, Inc.
Hazard
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Sold states
Distributed in the states of FL, TX, and VA.
Affected count
81 units
Manufactured in
750 Tower Rd, Suite A, Mundelein, IL, United States
Products
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2013Don't want to check this manually?
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