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Altis

Coloplast A/S · Model 519650 · UDI-DI 05708932467407

PAH Prescription
3
510(k) clearances
5,985
Adverse events (100 deaths)
1
Recalls
15
Facilities

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.