Z-2097-2013 Class II Terminated
FDA device recall Z-2097-2013 was initiated by Megadyne Medical Products, Inc. on August 7, 2013 and is designated Class II. 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. The recall status is terminated (terminated January 28, 2014). Affected quantity: 1816.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- August 7, 2013
- Termination Date
- January 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1816
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.
Distribution Pattern
Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
Code Information
Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058