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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SBA69DAN11 · UDI-DI 10197106977798

LRO Prescription
10
510(k) clearances
20,596
Adverse events (2 deaths)
1,057
Recalls
158
Facilities

Description

DAVINCI PACK

Recalls

DateFirmReason
2026-07-20Medline Industries, LPDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-07-14Cardinal Health 200, LLCCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09AVID Medical, Inc.Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

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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.