Recall Z-0725-2013
ConMed Corporation · initiated December 27, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Codes / lots: Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
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.
FDA-determined cause: Equipment maintenance
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.
Details
- Recall number
- Z-0725-2013
- Initiated
- December 27, 2012
- Posted by FDA
- January 24, 2013
- Terminated
- May 14, 2018
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 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, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
- Recalling firm
- ConMed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0718-2013 Class II | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0719-2013 Class II | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0720-2013 Class II | Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0721-2013 Class II | Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0722-2013 Class II | Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No.…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0723-2013 Class II | Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No.…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0724-2013 Class II | ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R)…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0726-2013 Class II | CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No.…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0727-2013 Class II | ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No.…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0728-2013 Class II | Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY --…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0729-2013 Class II | UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0730-2013 Class II | UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0731-2013 Class II | UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0732-2013 Class II | UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0733-2013 Class II | UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0734-2013 Class II | UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0735-2013 Class II | UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0736-2013 Class II | UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |
| Z-0737-2013 Class II | UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | 12/27/2012Terminated |