Recall Z-0507-2018— Microline Surgical, Inc.

Name: FDA recall Z-0507-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-13

Class II · Terminated

Class II FDA medical device recall by Microline Surgical, Inc., initiated 2017-07-13, terminated 2020-02-06. It names 2 FDA 510(k) clearances: K974066, K962119. Product: The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.. Reason: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure..

Recalling firm: Microline Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Terminated: 2020-02-06
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPSMicroline Pentax, Inc.·cleared 1998-01-22
K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTSMicroline Pentax, Inc.·cleared 1996-08-09

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

The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Reason for recall

The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

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