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FDA-Device2026-02-25Class II

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

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
150 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2026

Original summary

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950 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) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 2) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 150 units

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