Arthrogram Tray

FDA product code OII · Class II (moderate risk) · 21 CFR 892.1650 · Radiology

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
9recalls

Recalls

RecallProductFirmInitiated
Z-1888-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. Medline Industries, LP02/27/2026Open, Classified
Z-1850-2026 Class IIMedline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… Medline Industries, LP02/25/2026Open, Classified
Z-2127-2026 Class IIMedline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1422-2026 Class IIMedline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1619-2025 Class IIMedline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1452-2025 Class IIMedline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-3054-2024 Class IIMedline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2192-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-1097-2023 Class IISterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified