FDAFDA · Food and drugs·Recall number Z-2089-2014
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Published July 30, 2014 · Recall initiated: May 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Perouse Medical
- Distributor
- US.
- Lot
- Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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