Agency classClass IOur severity:Severe FDA (Devices)·Z-0497-2021·Announced 2020-12-02

Flexicare ProVu Video Stylet Recalled for Potential Airway Occlusion

Flexicare Medical Ltd. is recalling ProVu Single Use Video Stylets with ET Tubes because over-inflated cuffs may block the airway, making it difficult to ventilate patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

Plain-English summary

Flexicare Medical Ltd. is recalling 2,087 units of ProVu Single Use Video Stylets with Endotracheal (ET) Tubes. The affected products are distributed nationwide in the United States and include specific part and lot numbers for sizes 6.5, 7.0, 7.5, and 8.0.

The recall is due to a potential safety issue where the video stylet cuff may be over-inflated. If this occurs, it can cause occlusion of the corrugated section of the ET tube, leading to increased resistance to gas flow and difficulty in ventilating the patient.

Healthcare providers and facilities should stop using the affected devices and contact Flexicare Medical Ltd. for instructions on return or replacement. The product list and lot numbers were updated per a letter to customers dated December 23, 2020.

The recalled product

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
Manufacturer: Flexicare Medical Ltd.
Category: Medical Device — Airway Management
Hazard: airway-occlusion
ventilation-difficulty
Affected units: 2,087

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part/ Lot: 038-990-080U/ 191102901
200300486
200300539
200500068
200500069
200803210
191201567
200904316
200904319
038-990-075U/ 191102900
200100157
200300535
200300536
200300537
200402330
200402331
200402333
200402334
200402335
200402336

Distribution

Distributed nationwide across the United States.

Same manufacturer · Flexicare Medical Ltd.

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Same hazard · airway occlusion