VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in install
Summary
The FDA issued a Class II for VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Numb by Steris Corporation. Reason: Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout.
Details
Source
Device Recall
External ID
Z-0779-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Lot/Code Info: UDI: 10724995023833, 50724995023824 lot #230613
Quantity Affected: 857 boxes
Reason for Recall
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Distribution
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-12
Company
Mentor, OH
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 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
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 (Steris Corporation) 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 have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0779-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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