PlainRecalls
FDA Devices Moderate Class II Ongoing

VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

Reported: January 11, 2023 Initiated: December 12, 2022 #Z-0781-2023

Product Description

VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

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.

Details

Recalling Firm
Steris Corporation
Units Affected
105 boxes
Distribution
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Location
Mentor, OH

Frequently Asked Questions

What product was recalled? ▼
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes. Recalled by Steris Corporation. Units affected: 105 boxes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0781-2023.

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