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Recall Observatory FDA recall evidence

Device product

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

Z-0558-2025

October 25, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95702
Status
Ongoing
Classification
Class II
Quantity
100
Official record key
device-enforcement:Z-0558-2025

Official wording

Reason: Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

Code information: UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372

Distribution pattern: US Nationwide distribution in the state of NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.