ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx O
FDA device recall Z-0826-2013 · posted 2013-02-15 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
- Action taken
- ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. 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 response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers 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
- Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
- Date initiated
- 2013-01-28
- Date posted
- 2013-02-15
- Date terminated
- 2017-04-11
- Location
- Utica, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYFRECATOR, #733 (K800617) | Birtcher Corp. | 1980-05-02 |