Recall Z-2089-2014— Perouse Medical
Class II · Terminated
Class II FDA medical device recall by Perouse Medical, initiated 2012-05-10, terminated 2014-09-09. It names one FDA 510(k) clearance: K082755. Product: Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.. 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..
- Recalling firm
- Perouse Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-10
- Terminated
- 2014-09-09
- Firm location
- Irigny, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.