Recall Z-2089-2014
Perouse Medical · initiated May 10, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Codes / lots: 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.
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.
FDA-determined cause: Process control
Action taken
Perouse Medical initiated this recall by sending an e-mail notification to consignees on May 10, 2012. A formal written recall notification letter was sent to consignees on May 16, 2012. The recall letter, written in English, on company's letterhead, dated May 16, 2012, titled "VOLUNTARY BATCH RECALL Of FLAMINGO Inflations Devices", notified the consignee of the following: product information with codes and batch codes, product description, description of the potential default, reason for the recall action, instructions to the consignee, contact information and assistance. Response form "INVENTORY FORM".
Details
- Recall number
- Z-2089-2014
- Initiated
- May 10, 2012
- Posted by FDA
- July 22, 2014
- Terminated
- September 9, 2014
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 2,496 units
- Distribution
- US.
- Recalling firm
- Perouse Medical, Irigny