Steris Corporation: VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proces

Hazard

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 from the source

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 Quantity: 60 boxes Lot/code info: UDI: 10724995023840 lot #230613

UPC codes

10724995023840

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.