Z-2651-2023Class II

Puritan Bennett Cuff Pressure Manager, REF: 180-03

Name: Z-2651-2023 Puritan Bennett Cuff Pressure Manager, REF: 180-03
Creator: Covidien
Published: 2023-08-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-08-22 / Open, Classified / root cause: design

FDA source

Covidien began a recall of Puritan Bennett Cuff Pressure Manager, REF: 180-03 on 2023-08-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2651-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-09-29
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett Cuff Pressure Manager, REF: 180-03
Product code: BSK Cuff, Tracheal Tube, Inflatable
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.
Root cause tag: design
FDA 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 [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.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2651-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2651-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code BSK

K202874Class IIPuritan Bennett Cuff Pressure ManagerCovidien, LLC / cleared 2021-01-09

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)