Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within
Summary
The FDA issued a Class III for Verify SixCess Challenge Pack. Used to confirm that critical parameters of stea by Steris Corporation Hopkins Facility. Reason: Product contains incorrect chemical indicators in packaging..
Details
Source
Device Recall
External ID
Z-1736-2022
Action Date
2022-09-21
Status
Terminated
Category
device
Product Description
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Lot/Code Info: UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Quantity Affected: 619 boxes
Reason for Recall
Product contains incorrect chemical indicators in packaging.
Distribution
Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-10
Company
Mentor, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Steris Corporation Hopkins Facility) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation Hopkins Facility have FDA actions?
This is the only FDA action we have on record for Steris Corporation Hopkins Facility in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1736-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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