Z-3095-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- May 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
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.
Reason for Recall
Potential for an incomplete seal on the packaging tray.
Distribution Pattern
US Nationwide distribution.
Code Information
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.