E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Steri
FDA device recall Z-2097-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- Megadyne Medical Products, Inc.
- 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.
- Action taken
- 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 authorization and replacement or credit.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1816
- Distribution
- Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
- Date initiated
- 2013-08-07
- Date posted
- 2013-08-27
- Date terminated
- 2014-01-28
- Location
- Draper, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| E-Z CLEAN LAPAROSCOPIC ELECTRODE (K913281) | Megadyne Medical Products, Inc. | 1991-08-16 |