Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
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
- 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.
Lot numbers (20)
- 12031249
- 12031527
- 12031248
- 12041183
- 12041186
- 12031244
- 12031461
- 12031460
- 12021404
- 12031462
- 12031245
- 12021405
- 12031405
- 12031246
- 12021401
- 12041344
- 12031237
- 12031241
- 12021403
- 12041345
Distribution
Distribution scope not specified by the agency.
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