Recall Z-2221-2024— ASPEN SURGICAL
Class II · Ongoing
Class II FDA medical device recall by ASPEN SURGICAL, initiated 2024-06-03. It names one FDA 510(k) clearance: K913500. Product: 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..
- Recalling firm
- ASPEN SURGICAL
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-03
- Firm location
- Caledonia, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.