Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Summary
The FDA issued a Class II for Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt di by ASPEN SURGICAL. 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 compr.
Details
Source
Device Recall
External ID
Z-2221-2024
Action Date
2024-07-03
Status
Completed
Category
device
Product Description
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Lot/Code Info: UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
Quantity Affected: 1900 units
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.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-03
Company
Caledonia, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ASPEN SURGICAL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASPEN SURGICAL have FDA actions?
This is the only FDA action we have on record for ASPEN SURGICAL in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2221-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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