ASPEN SURGICAL: Device Recall
Recall #Z-2221-2024 · 06/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2221-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- ASPEN SURGICAL
- Status
- Ongoing
- Date Initiated
- 06/03/2024
- Location
- Caledonia, MI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1900 units
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.
Product Description
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Distribution Pattern
US Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.