Medline Industries, LP: Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide.
- Recall initiated
- 2026-01-07
- Code info
- 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
- Product quantity
- 150 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98329
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