Devices

Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only,

Model / Serial
Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
Product Description
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, || Product Usage: || A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Manufacturer
Teleflex Medical
1 Event
- Recall of Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only,

Manufacturer

Teleflex Medical

Manufacturer Address
Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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