FDA-Device2026-02-25Class II
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline Industries, LP
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
32 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2026Original summary
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L 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. 1) DYNJ50806L, UDI-DI: 10195327344672(each), 40195327344673(case), Lot Number: 23FBK937 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 32 units
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