FDA-Device2014-07-30Class II
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Perouse Medical
Hazard
Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.
Sold states
US.
Affected count
2,496 units
Manufactured in
135, Route Neuve, Irigny, France
Products
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2089-2014Don't want to check this manually?
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