FDA-Device2026-02-25Class IIPROCESSING DEFECT
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide.
Affected count
108 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1405-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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