Cuff Pressure Manager Power Inlet Dislodgment Prevents Charging
The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with a manufacturing defect that prevents proper patient treatment by disabling the charging function. No illnesses or injuries have been reported, placing it in the 'risk-of-harm' category without documented adverse events, warranting a Score of 3 (High).
Plain-English summary
Covidien is recalling 408 units of the Puritan Bennett Cuff Pressure Manager (REF: 180-03). The devices are affected by inadequate internal fixation of the power inlet port.
After several uses, the external power inlet becomes dislodged within the device housing due to this manufacturing defect. When dislodged, the device cannot be charged, preventing it from operating normally and potentially delaying patient treatment.
The affected devices were distributed to hospitals and facilities in 16 U.S. states (Alabama, New Jersey, Massachusetts, Michigan, New York, North Carolina, Colorado, Texas, Florida, Kentucky, Utah, California, Arizona, Kansas, Illinois, and Tennessee) and internationally to El Salvador, Sweden, and the Canary Islands. Users should check whether they have affected devices by matching the device serial numbers to those listed in the recall notice.
Facilities and healthcare providers with affected devices should contact Covidien immediately. The devices should not be used until the defect is corrected or the devices are replaced.
The recalled product
- Product
- Puritan Bennett Cuff Pressure Manager, REF: 180-03
- Manufacturer
- Covidien
- Category
- Medical Device
- Hazard
- charging-failure
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 10884521782495
- Serial Numbers: E223500003
- E223500004
- E223500005
- E223500006
- E223500007
- E223500008
- E223500009
- E223500010
- E223500011
- E223500012
- E223500013
- E223500014
- E223500015
- E223500016
- E223500017
- E223500018
- E223500019
- E223500020
- E223500021
Distribution
Distributed in 16 states:
- AL
- AZ
- CA
- CO
- FL
- IL
- KS
- KY
- MA
- MI
- NC
- NJ
- NY
- TN
- TX
- UT
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