Z-0558-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100
Product Description
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372