FDA-Device2020-12-02Class I
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Flexicare Medical Ltd.
Hazard
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
Sold states
US nationwide distribution.
Affected count
2087
Manufactured in
Cynon Valley Business Park, Mountain Ash, N/A, Rhondda Cynon Taff, N/A, United Kingdom
Products
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2021Don't want to check this manually?
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