Recall Z-2097-2013— Megadyne Medical Products, Inc.

Name: FDA recall Z-2097-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-07

Class II · Terminated

Class II FDA medical device recall by Megadyne Medical Products, Inc., initiated 2013-08-07, terminated 2014-01-28. It names one FDA 510(k) clearance: K913281. Product: E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.. Reason: Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-07
Terminated: 2014-01-28
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K913281 — E-Z CLEAN LAPAROSCOPIC ELECTRODEMegadyne Medical Products, Inc.·cleared 1991-08-16

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

E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

Reason for recall

Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.

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