PlainRecalls
FDA Devices Moderate Class II Terminated

Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

Reported: January 30, 2013 Initiated: December 27, 2012 #Z-0720-2013

Product Description

Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.

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.

Details

Recalling Firm
ConMed Corporation
Units 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, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.
Location
Utica, NY

Frequently Asked Questions

What product was recalled? ▼
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.. Recalled by ConMed Corporation. Units affected: 313,190 (total for all devices).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2013. Severity: Moderate. Recall number: Z-0720-2013.

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