Z-2221-2024 Class II
FDA device recall Z-2221-2024 was initiated by ASPEN SURGICAL on June 3, 2024 and is designated Class II. Reason for recall: 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. Affected quantity: 1900 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- June 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1900 units
Product Description
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Reason for Recall
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.
Distribution Pattern
US Nationwide
Code Information
UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982