FDA-Device2023-10-11Class II
Puritan Bennett Cuff Pressure Manager, REF: 180-03
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.
Sold states
US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands
Affected count
408
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2651-2023Don't want to check this manually?
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