ASPEN SURGICAL recalls Endoscopic Kittner Blunt Dissecting Instruments (Model KT-9101) due to potential sterile barrier seal defects that could compromise infection control.
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.
ASPEN SURGICAL is recalling endoscopic blunt dissecting instruments (Model KT-9101) because they may have a defective sterile barrier seal. This could allow contamination during medical procedures, posing a risk of infection.
The sterile barrier seal in the packaging may be defective, potentially compromising the instrument's sterility. If the seal fails during use, the instrument could become contaminated, increasing infection risk during medical procedures.
Healthcare professionals using these instruments for surgical procedures are most at risk. Patients receiving procedures with these instruments could face infection risks.
Check for Model Number KT-9101 on the instrument. Lot Numbers 389571, 389576, 390981, and 390982 are affected. These instruments were sold with UDI-DI: 00840113214006.
Identify the model number on the instrument; affected units are Model KT-9101.
Affected instruments have Lot Numbers 389571, 389576, 390981, or 390982.
The affected products may have been packaged with a defect in the sterile barrier seal, which could compromise the integrity of the sterile barrier during use.
If the sterile barrier seal is compromised, the instrument could become contaminated, increasing the risk of infection during medical procedures.
Check for Model Number KT-9101 and Lot Numbers 389571, 389576, 390981, or 390982 on the instrument.
We’ve drafted a message you can send ASPEN SURGICAL to request your refund or repair — edit it as you like.
Subject: Recall Z-2221-2024 — ASPEN SURGICAL ASPEN SURGICAL Hello, I own a ASPEN SURGICAL that is covered by recall Z-2221-2024 from ASPEN SURGICAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
