PlainRecalls
FDA Devices Moderate Class II Ongoing

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

Reported: July 3, 2024 Initiated: June 3, 2024 #Z-2221-2024

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.

Details

Recalling Firm
ASPEN SURGICAL
Units Affected
1900 units
Distribution
US Nationwide
Location
Caledonia, MI

Frequently Asked Questions

What product was recalled?
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101. Recalled by ASPEN SURGICAL. Units affected: 1900 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2221-2024.