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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (difficulty ventilating patients) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
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.
- 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.
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