VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installatio

FDA device recall Z-0779-2023 · posted 2023-01-03 · Open, Classified

Recall details

Recalling firm

Steris Corporation

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.

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

FRC

Quantity affected

857 boxes

Distribution

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

Date initiated

2022-12-12

Date posted

2023-01-03

Location

Mentor, OH

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