Recall Z-1698-2019— Microline Surgical, Inc.

Name: FDA recall Z-1698-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-22

Class II · Terminated

Class II FDA medical device recall by Microline Surgical, Inc., initiated 2019-03-22, terminated 2020-07-30. It names one FDA 510(k) clearance: K062257. Product: TLS2 Thermal Ligating Shears, Catalog Number 132-131D. Reason: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures..

Recalling firm: Microline Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-22
Terminated: 2020-07-30
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K062257 — STARION INSTRUMENTS THERMAL LITIGATING SHEARSStarion Instruments·cleared 2006-10-10

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

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Reason for recall

The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

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