Puritan Bennett Cuff Pressure Manager, REF: 180-03
FDA device recall Z-2651-2023 · posted 2023-09-29 · Open, Classified
Recall details
- Recalling firm
- Covidien
- Reason for recall
- 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.
- Action taken
- 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 at 800-962-9888, Option 2. Quality problems can be reported to Quality Assurance at 800-255-6774 option 4.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- BSK
- Quantity affected
- 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
- Date initiated
- 2023-08-22
- Date posted
- 2023-09-29
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Puritan Bennett Cuff Pressure Manager (K202874) | Covidien, LLC | 2021-01-09 |