Recall Z-1741-2018— Microline Surgical, Inc.

Name: FDA recall Z-1741-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-01

Class II · Terminated

Class II FDA medical device recall by Microline Surgical, Inc., initiated 2017-11-01, terminated 2019-09-17. It names one FDA 510(k) clearance: K962119. Product: ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.. Reason: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier..

Recalling firm: Microline Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-01
Terminated: 2019-09-17
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

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

ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Reason for recall

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

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