Z-0497-2021 Class I Terminated
FDA device recall Z-0497-2021 was initiated by Flexicare Medical Ltd. on September 22, 2020 and is designated Class I. 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. The recall status is terminated (terminated July 29, 2024). Affected quantity: 2087.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2020
- Initiation Date
- September 22, 2020
- Termination Date
- July 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2087
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.
Distribution Pattern
US nationwide distribution.
Code Information
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, 200402337, 200403976, 200404287, 200500991, 200500992, 200501790; 038-990-070U/ 201000813, 201100558; 038-990-065U/ 201000808, 202002462 *Note: product and lot number list updated per 12/23/2020 letter to customers