Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissu...
FDA Recall #Z-2221-2024 — Class II — June 3, 2024
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.
Recalling Firm
ASPEN SURGICAL — Caledonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1900 units
Distribution
US Nationwide
Code Information
UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated