Z-1405-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- January 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 units
Product Description
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Reason for Recall
Medline 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 packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
1) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027; 2) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25FBD161; 3) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBN454; 4) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBG142; 5) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBE995; 6) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25DBE771; 7) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25CBB549; 8) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBS071; 9) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBB895; 10) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24FBK537; 11) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24CBK339; 12) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24ABH890; 13) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 23KBA331; 14) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 22KBD675