Recall Z-2651-2023— Covidien
Class II · Ongoing
Class II FDA medical device recall by Covidien, initiated 2023-08-22. It names one FDA 510(k) clearance: K202874. Product: Puritan Bennett Cuff Pressure Manager, REF: 180-03. Reason: 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..
- Recalling firm
- Covidien
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-22
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.