Recall Z-0497-2021— Flexicare Medical Ltd.

Name: FDA recall Z-0497-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-22

Class I · Terminated

Class I FDA medical device recall by Flexicare Medical Ltd., initiated 2020-09-22, terminated 2024-07-29. It names one FDA 510(k) clearance: K091591. 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: 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..

Recalling firm: Flexicare Medical Ltd.
Classification: Class I
Status: Terminated
Initiated: 2020-09-22
Terminated: 2024-07-29
Firm location: Rhondda Cynon Taff, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBESFlexicare Medical, Ltd.·cleared 2009-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.