Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
FDA Recall Z-1986-2014 · Posted 2014-07-02
Recalling FirmMicroline Surgical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-05-12
Date Terminated2015-08-13
Product Quantity150 units
Reason for Recall
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Firm Action
Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.