FDA recall Z-2651-2023

Product

Puritan Bennett Cuff Pressure Manager, REF: 180-03

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

Key facts

Status

Ongoing

Initiation date

2023-08-22

Report date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2651-2023