VERIFY Dual Species Self-Contained Biological recall
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine…
Why was VERIFY Dual Species Self-Contained Biological 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10724995023833, 50724995023824 lot #230613
- Product
- VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine…
- Recalling firm
- Steris Corporation
- Quantity
- 857 boxes
- Distribution
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- Recall date
- January 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)