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Dover

Cardinal Health 200, LLC · Model 400612 · UDI-DI 10192253029093

KOD Prescription
10
510(k) clearances
17,205
Adverse events (30 deaths)
108
Recalls
112
Facilities

Description

DOVER VINYL URETHRAL CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 12 FR (4.0 MM)

Recalls

DateFirmReason
2026-06-25C.R. Bard IncDue to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2025-06-03C.R. Bard IncCather packaging may contain the incorrect French size.
2025-06-03C.R. Bard IncCather packaging may contain the incorrect French size.
2023-12-04Cardinal Health 200, LLCConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2022-09-20TELEFLEX LLCProduct may not be sterile
2022-01-27C.R. Bard IncThere is a potential to leak from the catheter where it connects to the drain bag
2022-01-27C.R. Bard IncThere is a potential to leak from the catheter where it connects to the drain bag
2021-01-11C.R. Bard, Inc.The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
2020-04-30Covidien LlcTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead
2020-04-30Covidien LlcTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead

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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.