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Gyrus ACMI
Gyrus ACMI, LLC · Model 7089-0844 · UDI-DI 00821925034853
EMX
Prescription
1
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
53
Facilities
Description
Blu K-Style Sinus Pack 3.5 cm x .9 cm x 1.2 cm, Bacteriostatic
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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