Device 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.
Z-2097-2013
Product summary
- Event
- Event 65995
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1816
- Official record key
device-enforcement:Z-2097-2013
Official wording
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.
Code information: Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058
Distribution pattern: Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
Derived failure modes
-
Unknown
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.