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Desara One

Caldera Medical, Inc. · Model CAL-DS2113 · UDI-DI 00890594000971

PAHPWJ Prescription
1
510(k) clearances
6,009
Adverse events (100 deaths)
1
Recalls
15
Facilities

Description

Single Incision Sling System (3/box)

Recalls

DateFirmReason
2015-10-26AstoraThe lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.