—#197438

Product

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 processes

FDA product code: FRC — Indicator, Biological Sterilization Process
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K083665
Affected lot / code info: UDI: 10724995023840 lot #230613

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.

Root cause (FDA determination)

Employee error

Action the firm took

Steris issued Urgent Medical Device Recall letters to Customers and Distributors on 12/12/2022 via FedEX. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963. If you have questions regarding this recall, please contact Melissa Gonsalves, Senior Product Manager at (440) 392-7043, or STERIS Customer Service at 1-800-548-4873.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA

Timeline

Recall initiated: 2022-12-12
Posted by FDA: 2023-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197438. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.