Puritan Bennett recallZ-2651-2023 · Covidien · initiated Aug 22, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-2651-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 22, 2023
- Posted by the FDA
- Sep 29, 2023
- Recalling firm
- Covidien
- Quantity
- 408
- Product code
- BSK
- FDA submissions
- K202874
- Distribution
- US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands
Product description
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Code information (models, lots, serial numbers)
Show the full code information (5k characters)
UDI-DI: 10884521782495, Serial Numbers: E223500003, E223500004, E223500005, E223500006, E223500007, E223500008, E223500009, E223500010, E223500011, E223500012, E223500013, E223500014, E223500015, E223500016, E223500017, E223500018, E223500019, E223500020, E223500021, E223500022, E223500023, E223500024, E223500025, E223500026, E223500027, E223500028, E223500029, E223500030, E223500031, E223500032, E223500054, E223500055, E223500079, E223500080, E223500081, E223500082, E223500083, E223600009, E223600010, E223600011, E223600012, E223600013, E223600014, E223600015, E223600016, E223600017, E223600018, E223600019, E223600020, E223600021, E223600022, E223600023, E223600024, E223600042, E223600070, E223600071, E223600072, E223600073, E223600074, E223600075, E223600076, E223600077, E223600078, E223600079, E223600080, E223600081, E223600082, E223600083, E223600084, E223600085, E223600086, E223600087, E223600088, E223600089, E223600090, E223600092, E223600093, E223600095, E223600096, E223600097, E223600098, E223600099, E223600100, E224900001, E224900002, E224900003, E224900004, E224900005, E224900006, E224900007, E224900008, E224900009, E224900010, E224900011, E224900012, E224900013, E224900014, E224900015, E224900017, E224900018, E224900019, E224900020, E224900021, E224900022, E224900023, E224900024, E224900025, E224900026, E224900027, E224900028, E224900029, E224900030, E224900031, E224900032, E224900033, E224900034, E224900035, E224900036, E224900037, E224900039, E224900040, E224900041, E224900042, E224900043, E224900044, E224900045, E224900047, E224900048, E224900049, E224900050, E224900052, E224900053, E224900055, E224900056, E224900057, E224900058, E224900059, E224900060, E224900061, E224900062, E224900064, E224900065, E224900066, E224900067, E224900068, E224900069, E224900070, E224900072, E224900073, E224900074, E224900075, E224900076, E224900077, E224900078, E224900081, E224900082, E224900083, E224900084, E224900085, E224900087, E224900091, E224900092, E224900093, E224900094, E224900095, E224900098, E224900099, E224900100, E225000001, E225000002, E225000003, E225000004, E225000005, E225000006, E225000007, E225000011, E225000012, E225000013, E225000014, E225000015, E225000016, E225000017, E225000018, E225000019, E225000020, E225000021, E225000022, E225000023, E225000024, E225000025, E225000026, E225000027, E225000029, E225000031, E225000032, E225000033, E225000034, E225000035, E225000036, E225000037, E225000038, E225000039, E225000040, E225000041, E225000042, E225000043, E225000044, E225000045, E225000046, E225000047, E225000048, E225000049, E225000050, E225000051, E225000052, E225000053, E225000054, E225000055, E225000056, E225000057, E225000058, E225000059, E225000060, E225000061, E225000062, E225000063, E225000064, E225000065, E225000066, E225000067, E225000068, E225000069, E225000070, E225000071, E225000072, E225000073, E225000075, E225000076, E225000077, E225000078, E225000079, E225000080, E225000081, E225000082, E225000083, E225000084, E225000085, E225000086, E225000087, E225000088, E225000089, E225000090, E225000091, E225000092, E225000093, E225000094, E225000095, E225000096, E225000097, E225000098, E225000099, E225000100, E230200001, E230200002, E230200003, E230200004, E230200005, E230200006, E230200007, E230200008, E230200009, E230200010, E230200011, E230200012, E230200013, E230200014, E230200015, E230200016, E230200017, E230200018, E230200019, E230200020, E230200021, E230200022, E230200023, E230200024, E230200025, E230200027, E230200028, E230200029, E230200030, E230200031, E230200032, E230200033, E230200034, E230200035, E230200036, E230200037, E230200038, E230200039, E230200040, E230200041, E230200042, E230200043, E230200044, E230200045, E230200046, E230200048, E230200049, E230200050, E230200051, E230200052, E230200053, E230200054, E230200056, E230200057, E230200058, E230200059, E230200060, E230200061, E230200062, E230200064, E230200065, E230200066, E230200067, E230200068, E230200069, E230200070, E230200071, E230200072.E230200073, E230200074, E230200075, E230200076, E230200077, E230200078, E230200079, E230200080, E230200081, E230200082, E230200083, E230200085, E230200086, E230200087, E230200088, E230200089, E230200090, E230200091, E230200092, E230200095, E230200096, E230500006, E230500007, E230500008, E230500009, E230500010, E230500011, E230500031, E230500032, E230500033, E230500034, E230500035, E230500036, E230500037, E230500038, E230500039, E230500040, E230500041, E230500042, E230500043, E230500044, E230500045, E230500046, E230500047, E230500048, E230500049, E230500050, E230500051, E230500052, E230500053, E230500054, E230500055, E230500056, E230500057, E230500058, E230500059, E230500060, E230500061, E230500062, E230500063, E230500064, E230500065, E230500066, E230500092, E230500093, E230500094, E230500103, E230500104, E230500105, E230500106, E230500107, E230500108, E230500109, E230500110, E230500111, E230500112, E230900079, E230900080
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Puritan Bennett 180-03Covidien LP · Cuff, tracheal tube, inflatable1 recall23 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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