FDA Device Intelligence
HomeCardinal Health, Inc. › Covidien

Covidien

Cardinal Health, Inc. · Model 461000 · UDI-DI 10884521189225

KYX
10
510(k) clearances
262
Adverse events (3 deaths)
17
Recalls
275
Facilities

Description

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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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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.