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Cardinal Health

GRI Medical & Electronic Technology Co., Ltd. · Model Model 25-2020 · UDI-DI 16931918157672

KXF
10
510(k) clearances
558
Adverse events (6 deaths)
2
Recalls
373
Facilities

Description

Sponge Stick_ Vaginal_Non-Sterile_800ea/cs

Recalls

DateFirmReason
2023-02-03Avanos Medical, Inc.Incorrect expiration date.
2013-03-26Owens & Minor Distribution, Inc.Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loo

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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.