Reported Jan 11, 2023 · Ongoing
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- VERIFY Steam Test Pack (20
- Tests and 5 controls) Item NumberS3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Lot codes and dates
- UDI10724995023840 lot #230613
- Amount recalled
- 60 boxes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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