FDA Enforcement
Class II
Ongoing
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.
Recall: Z-3095-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3095-2024
- Event ID
- 95126
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 18, 2024
- Initiation Date
- May 7, 2024
- Classification Date
- September 10, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
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
Potential for an incomplete seal on the packaging tray.
Code Info
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
Distribution
US Nationwide distribution.
Quantity
46 units