Recall Z-1986-2014— Microline Surgical, Inc.

Name: FDA recall Z-1986-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-12

Class II · Terminated

Class II FDA medical device recall by Microline Surgical, Inc., initiated 2014-05-12, terminated 2015-08-13. It names one FDA 510(k) clearance: K981389. Product: Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221. Reason: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw.

Recalling firm: Microline Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Terminated: 2015-08-13
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K981389 — DISPOSABLE RE-NEW FORCEPSMicroline Pentax, Inc.·cleared 1998-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221

Reason for recall

Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

Data sourced from openFDA. This site is unofficial and independent of the FDA.