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Covidien recalls Puritan Bennett Cuff Pressure Manager, REF: 180-03
Recalled October 11, 2023 · FDA recall Z-2651-2023 · Covidien
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. · FDA Class II
Units
408
Sold at
US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands
Description
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.
Product
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Manufacturer(s)
Covidien
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →