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Perouse Medical recalls Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monit
Recalled July 30, 2014 · FDA recall Z-2089-2014 · 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. · FDA Class II
Units
2,496 units
Sold at
US.
Description
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.
Product
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Manufacturer(s)
Perouse Medical
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →