Reported Jul 30, 2014 · Terminated
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and…
Perouse Medical
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: Perouse Medical · 135, Route Neuve · Irigny · N/A
Is this the product you have?
- Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
- Lot codes and dates
- Model 0218TA and 0218TB
- Manufacturing Lot Numbers12031275 and 12031242. EXP.: 02/2017
- Batches
12031526120312491203152712031248120411831204118612031244120314611203146012021404120314621203124512021405120314051203124612021401120413441203123712031241120214031204134512041184120314971203124012021194120315241203148012041181120312751203124212021450120214491204118512031525120312471202140212021448
- Amount recalled
- 2,496 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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