Recall Z-2097-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
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
| Date | Aug 27, 2013 (initiated Aug 7, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Megadyne sent an Urgent: Medical Device Recall Field Safety Notice dated August 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were also notified with follow-up phone calls and email beginning on August 7, 2013. Customers were instructed to examine their stock immediately to determine if you have any of the products from the affected lots on hand. If so, please remove form service/discontinue use and contact Megadyne Customer Service at 1 (801) 576-9669 or (800) 747-6110 (USA) for return auth |
| Quantity | 1816 |
| Distribution | Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913281 | E-Z CLEAN LAPAROSCOPIC ELECTRODE Megadyne Medical Products, Inc., Aug 16, 1991 |