Device product
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Z-2106-2026
Product summary
- Event
- Event 98642
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 892 units
- Official record key
device-enforcement:Z-2106-2026
Official wording
Reason: 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.
Code information: 1) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23BMB940; 2) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23FMF503; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 6) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 7) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 8) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBM234; 9) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBO757; 10) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23LBQ441; 11) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24BBG312; 12) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24EBM141; 13) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24HBW695; 14) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24IBN719; 15) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455; 16) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25ABG235; 17) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25BBO546; 18) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBG687; 19) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBQ261; 20) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBF535; 21) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBW469; 22) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25GBV755
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
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.