Z-0497-2021Class I

ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/...

Name: Z-0497-2021 ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/...
Creator: Flexicare Medical Ltd.
Published: 2020-09-22
License: https://open.fda.gov/license/

Flexicare Medical Ltd. / initiated 2020-09-22 / Terminated / root cause: design

FDA source

Flexicare Medical Ltd. began a recall of 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... on 2020-09-22. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0497-2021
Classification: Class I
Status: Terminated
Initiated: 2020-09-22
Posted: 2020-11-26
Terminated: 2024-07-29
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
Product code: BTR Tube, Tracheal (W/Wo Connector)
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.
Root cause tag: design
FDA 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 Customers were asked to do the following: Affected product from the lot numbers identified should be withdrawn from use and quarantined.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 [email protected].
Quantity in commerce: 2087
Distribution: US nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0497-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0497-2021	Class I	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-26

Product code BTR

K091591Class IIFlexicare Medical Endotracheal TubesFlexicare Medical, Ltd. / cleared 2009-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)