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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SAN23AGDH5 · UDI-DI 10197106197370

OII Prescription
0
510(k) clearances
6
Adverse events
9
Recalls
17
Facilities

Description

ARTHROGRAM TRAY

Recalls

DateFirmReason
2026-02-27Medline Industries, LPUnapproved design changes to the products outside of the 510(k) clearance.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-03-03MEDLINE INDUSTRIES, LP - NorthfieldThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2025-02-11MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2022-11-17MEDLINE INDUSTRIES, LP - NorthfieldSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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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.