Covidien: Puritan Bennett Cuff Pressure Manager, REF: 180-03

Hazard

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.

Details from the source

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. Distribution: US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands Quantity: 408 Lot/code info: 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, E2249000

UPC codes

10884521782495

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.