Endoscopic Kittner Surgical Instrument Recalled for Sterile Barrier Defect
ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical instrument with a potential sterile barrier defect. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing it in the High severity category as a risk-of-harm product without yet-reported injury.
Plain-English summary
ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument, Model KT-9101, distributed nationwide in the United States. The instrument is intended for blunt dissection of tissue during endoscopic surgical procedures.
The affected products may have been packaged with a defect in the sterile barrier seal. This defect may compromise the integrity of the sterile barrier.
The recalled instruments are identified by UDI-DI 00840113214006 and Lot Numbers 389571, 389576, 390981, and 390982.
The recalled product
- Product
- Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
- Manufacturer
- ASPEN SURGICAL
- Affected units
- 1,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00840113214006
- Lot Numbers: 389571
- 389576
- 390981
- 390982
Distribution
Distributed nationwide across the United States.
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