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Desara Blue
Caldera Medical, Inc. · Model CAL-DS01B · UDI-DI 00890594000674
OTO
Prescription
1
510(k) clearances
4,780
Adverse events (24 deaths)
1
Recalls
20
Facilities
Description
Desara Blue sling system for female stress urinary incontinence.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-12 | Coloplast Manufacturing US, LLC | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging. |
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