Recall Z-0497-2021 ยท BTR Tube, Tracheal (W/Wo Connector)
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
| Date | Nov 26, 2020 (initiated Sep 22, 2020) |
| Status | Terminated |
| 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 Customers were asked to do the following: Affected product from the lot numbers identified should be withdrawn from use and quarantined.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 |
| Quantity | 2087 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES Flexicare Medical, Ltd., Jun 17, 2009 |