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Recall Observatory FDA recall evidence

Device product

Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A

Z-1837-2026

February 25, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98599
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1837-2026

Official wording

Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Code information: 1) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 25CLA242; 2) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 24LLA758

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.