Reported Oct 11, 2023 · Ongoing
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Covidien
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- Puritan Bennett Cuff Pressure Manager
- REF180-03
- Lot codes and dates
- UDI-DI10884521782495
- Serial Numbers
408 of 408 codes
E223500003E223500004E223500005E223500006E223500007E223500008E223500009E223500010E223500011E223500012E223500013E223500014E223500015E223500016E223500017E223500018E223500019E223500020E223500021E223500022E223500023E223500024E223500025E223500026E223500027E223500028E223500029E223500030E223500031E223500032E223500054E223500055E223500079E223500080E223500081E223500082E223500083E223600009E223600010E223600011E223600012E223600013E223600014E223600015E223600016E223600017E223600018E223600019E223600020E223600021E223600022E223600023E223600024E223600042E223600070E223600071E223600072E223600073E223600074E223600075
- Amount recalled
- 408
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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