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Recall Observatory FDA recall evidence

Device product

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

Z-2221-2024

June 03, 2024

Class II

Product summary

Firm
ASPEN SURGICAL
Event
Event 94778
Status
Completed
Classification
Class II
Quantity
1900 units
Official record key
device-enforcement:Z-2221-2024

Official wording

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.

Code information: UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982

Distribution pattern: US Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier may be compromised