Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2089-2014
Related Recalls
Complaints regarding broken blister.
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure