FDA recall Z-0497-2021

Product

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

Reason for recall

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.

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-09-22

Report date

2020-12-02

Termination date

2024-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rhondda Cynon Taff, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2021