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AURADONICS
AURADONICS INC. · Model 811-004 · UDI-DI 00810033834646
ECI
Prescription
10
510(k) clearances
18
Adverse events
3
Recalls
121
Facilities
Description
LATEX ELASTICS 3/16" 4.5 oz. - AMBER, 50 bags of 100, see www.auradonics.com
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-21 | G & H Wire Company | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy |
| 2021-01-21 | G & H Wire Company | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the dev |
| 2011-08-18 | Biomet Microfixation, Inc. | On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". |
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