Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2221-2024 — Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

U.S. FDA — Device Enforcement · United States · 2024-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2221-2024
Date of alert
2024-06-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ASPEN SURGICAL
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840113214006
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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