Flexicare Medical Ltd. recalls 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…

Recall date

September 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0497-2021

FDA classification

Class I

Brand / firm

Flexicare Medical Ltd.

Sold / distributed

US nationwide distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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