Z-2089-2014 Class II Terminated
FDA device recall Z-2089-2014 was initiated by Perouse Medical on May 10, 2012 and is designated Class II. Reason for recall: 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 en… The recall status is terminated (terminated September 9, 2014). Affected quantity: 2,496 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2014
- Initiation Date
- May 10, 2012
- Termination Date
- September 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,496 units
Product Description
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Reason for Recall
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.
Distribution Pattern
US.
Code Information
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.