Recall Z-2089-2014 ยท MAV Syringe, Balloon Inflation
Perouse Medical
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
| Date | Jul 22, 2014 (initiated May 10, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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 "INVEN |
| Quantity | 2,496 units |
| Distribution | US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082755 | SEDAT FLAMINGO Sedat, Dec 15, 2008 |