FDAFDA · Food and drugs·Recall number Z-2221-2024
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Published July 3, 2024 · Recall initiated: June 3, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ASPEN SURGICAL
- Distributor
- US Nationwide
- Lot
- UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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