Recall Z-2557-2016— Medtronic

Name: FDA recall Z-2557-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-08

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2016-07-08, terminated 2018-08-08. It names one FDA 510(k) clearance: K926481. Product: Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable. Reason: Potential for compromise of the package resulting in a breach of the sterile barrier.

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2016-07-08
Terminated: 2018-08-08
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K926481 — VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSETValleylab, Inc.·cleared 1994-02-12

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

Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

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