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Terminated

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222

FDA Recall Z-1987-2014 · Posted 2014-07-02

Recalling FirmMicroline Surgical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-05-12
Date Terminated2015-08-13
Product Quantity6290 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.

K981389DISPOSABLE RE-NEW FORCEPSMicroline Pentax, Inc. · 1998-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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