Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
FDA Recall Z-2089-2014 · Posted 2014-07-22
Recalling FirmPerouse Medical
Recall StatusTerminated
Product CodeMAV
Date Initiated2012-05-10
Date Terminated2014-09-09
Product Quantity2,496 units
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.
Firm Action
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".
Root Cause
Process control
Distribution Pattern
US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.