FDA (Devices) recall action 63981

ConMed Corporation recalled 20 products on 2013-01-30

The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.

Products: 20
Announced: 2013-01-30
Critical: 0
Units: 6,263,800

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–20 of 20

HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls Electrosurgical ENT Needle Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical ENT needle electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls ABC Nozzles Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 ABC Nozzles because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrode Blades Due to Seal Compromise
ConMed is recalling UltraClean Accessory Electrode 4 inch Coated Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls Electrosurgical Safety Holsters Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical safety holsters because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls Goldvac UltraClean Electrode Blades Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrode Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
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.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls Electrosurgical Tip Cleaners Due to Compromised Sterile Seals
ConMed is recalling 313,190 Electrosurgical Tip Cleaners because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Seal Compromise
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls TUR Endoscopic Cables Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 TUR/Endoscopic Cables because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
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.
Category
Distribution
1 state
HighFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Distribution
1 state