Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect

Plain-English summary

Perouse Medical, a manufacturer based in France, has initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflation Devices. These medical devices are intended for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters. The recall affects 2,496 units of Model 0218TA and 0218TB, which were distributed in the United States.

The recall was initiated due to a potential water-tightness default. This defect could cause an air entry when the plunger is positioned around 20 mL. The affected units include specific manufacturing lot numbers and batches, with an expiration date of 02/2017.

Healthcare providers and facilities that have received these devices should stop using them and contact Perouse Medical for further instructions on the recall process. Consumers are not directly affected as these are professional medical devices used in clinical settings.

The recalled product

Product

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

Category

Medical Device — Cardiovascular

Hazard

• air-entry
• device-defect

Affected units

2,496

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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