Z-2221-2024 Class II Ongoing

Recalled by ASPEN SURGICAL — Caledonia, MI

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