Device product
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Z-3095-2024
Product summary
- Event
- Event 95126
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-3095-2024
Official wording
Reason: Potential for an incomplete seal on the packaging tray.
Code information: Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
incomplete seal