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Vaginal Applicator APPLISIL

UNION PLASTIC · Model Applicator 2.5g - Flowpack by 1 · UDI-DI 03701225740845

KYX
10
510(k) clearances
263
Adverse events (3 deaths)
17
Recalls
277
Facilities

Description

Medical Device with Measuring Function. Use for the dosage and administration of drugs to human.

Recalls

DateFirmReason
2024-03-04Avanos Medical, Inc.The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2024-03-04Avanos Medical, Inc.The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2024-03-04Avanos Medical, Inc.The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
2023-03-20Baxter Healthcare CorporationExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.
2022-07-22Baxter Healthcare CorporationThere is a potential of the packaging not maintaining a sterile barrier for the tip caps.

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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.