FDA Enforcement
Class II
Completed
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Recall: Z-2221-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2221-2024
- Event ID
- 94778
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- ASPEN SURGICAL
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- June 3, 2024
- Classification Date
- June 27, 2024
- Address
- 5120 Beltway Dr Se, Caledonia, MI, 49316, United States
Description
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Reason
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Code Info
UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
Distribution
US Nationwide
Quantity
1900 units