Events

Recall of Device Recall Perouse Flamingo Angiographic injector/syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perouse Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68795
  • Event Risk Class
    Class 2
  • Event Number
    Z-2089-2014
  • Event Initiated Date
    2012-05-10
  • Event Date Posted
    2014-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128754
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Angiographic injector/syringe, balloon inflation syringe. - Product Code MAV
  • 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.
  • 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".

Device

Device Recall Perouse Flamingo Angiographic injector/syringe
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US.
  • Product Description
    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
  • Manufacturer
    Perouse Medical

Manufacturer

Perouse Medical
  • Manufacturer Address
    Perouse Medical, 135, Route Neuve, Irigny France
  • Manufacturer Parent Company (2017)
    Perouse Medical
  • Source
    USFDA