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Outake®

Merit Medical Systems, Inc. · Model 00884450052587 · UDI-DI 00884450052587

ODY Prescription
2
510(k) clearances
1
Adverse events
1
Recalls
9
Facilities

Recalls

DateFirmReason
2024-06-11Merit Medical Systems, Inc.Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma

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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.