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Assure® Slide Pill Swallowing Aid zero

ARKRAY USA, INC. · Model 1000003 · UDI-DI 00015482100032

NXB
3
510(k) clearances
82
Adverse events (3 deaths)
1
Recalls
132
Facilities

Description

Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)

Recalls

DateFirmReason
2021-07-02Hero HealthDue to dispenser prompting for a missed dose that had already been dispensed

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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.