Devices

Device Recall IMA/ENT Blade Electrode

Model / Serial
Catalog number: 809335, Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and countries of Canada, Australia and Singapore.
Product Description
WECK IMA/ENT Blade Electrode ¿ (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC || The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.
Manufacturer
Telefelx Medical
1 Event
- Recall of Device Recall IMA/ENT Blade Electrode

Manufacturer

Telefelx Medical

Manufacturer Address
Telefelx Medical, 2917 Weck Drive, Durham NC 27709
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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