Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monit
FDA device recall Z-2089-2014 · posted 2014-07-22 · Terminated
Recall details
- Recalling firm
- Perouse Medical
- 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.
- 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".
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAV
- Quantity affected
- 2,496 units
- Distribution
- US.
- Date initiated
- 2012-05-10
- Date posted
- 2014-07-22
- Date terminated
- 2014-09-09
- Location
- Irigny, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEDAT FLAMINGO (K082755) | Sedat | 2008-12-15 |