Recall Z-2651-2023 ยท BSK Cuff, Tracheal Tube, Inflatable
Covidien
Puritan Bennett Cuff Pressure Manager, REF: 180-03
| Date | Sep 29, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| Reason | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay. |
| Root cause | Component design/selection |
| Action | On 8/22/23 Medtronic mailed recall notices to risk managers and directors of respiratory care informing them of the following: 1) Discontinue use, quarantine, and return affected devices to the firm. 2) Complete and return the customer confirmation form via email to it to rs.gmbfcamitg@medtronic.com. 3) Forward the notice to all those who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers has been transferred or distributed. If you have any questions regarding this communication, contact customer service |
| Quantity | 408 |
| Distribution | US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202874 | Puritan Bennett Cuff Pressure Manager Covidien, LLC, Jan 9, 2021 |