ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx O
FDA device recall Z-0718-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
- Action taken
- ConMed sent an Urgent Field Safety Notice dated January 7, 2013, and Business Reply Form to all affected customers via USPS Priority Mail. International notices were sent via FedEx International Priority on December 27, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 Customer were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 313,190 (total for all devices)
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexic
- Date initiated
- 2012-12-27
- Date posted
- 2013-01-24
- Date terminated
- 2018-05-14
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYFRECATOR, #733 (K800617) | Birtcher Corp. | 1980-05-02 |