FDA Medical Device Recalls (openFDA)
Flexicare Medical Ltd.: 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
- Recall number
- Z-0497-2021
- Recalling firm
- Flexicare Medical Ltd.
- 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
- Status
- Terminated
- Initiated
- 2020-09-22
- Posted
- 2020-11-26
- Terminated
- 2024-07-29
- 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.
- Root cause
- Component design/selection
- Action
- On 09/22/2020, Sales Representatives started notifying customers of this recall verbally. Customers were asked to quarantine all affected product and ensure it is not used until further notice. On 12/23/2020, Medical Device Recall notices started being mailed to customers. Customers were asked to do the following: Affected product from the lot numbers identified should be withdrawn from use and quarantined. The lot number can be found on both the outer box label and on the individual packaging. Return the Acknowledgment and Receipt Form as soon as possible. If this letter is not addressed to your facility or you have been passed the Notification from another facility, please provide the name and contact details of the facility you represent in the Acknowledgement and Receipt Form. If you are a distributor, please acknowledge receipt and understanding of this field safety notice and relay this field safety notice to all end users. On receipt of the completed Acknowledgement and Receipt Form, you will be contacted by a representative who will arrange for collection of the quarantined devices. If you have any questions, please call the firm at 949-450-9999 ext. 102, or via email at RecallUSA@flexicare.com.
- Quantity
- 2087
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K091591"]
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3006363476
- Firm city
- Taff
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28