Facility
Perouse Medical
3 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3006942524 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | Route du Manoir FRANCE Oise, FR 60173 |
| Registration status | Active · expires 2026 |
| Parent company | Perouse Medical (owner-operator 10024483) |
| Brand names | MyShell Lite |
Devices registered here (1)
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassProduct code DTL · Class II · Cardiovascular · 21 CFR 870.4290
Recalls & enforcement
- Class IITerminated2017-04-05Complaints regarding broken blister.
- Class IITerminated2014-10-06Additional 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
- Class IITerminated2012-05-10Perouse 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.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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