Steris Corporation: VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Steris Corporation
- Product
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
- Reason / hazard
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-08-31
- Code info
- UDI:10724995023864 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027
- Product quantity
- 233
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mentor
- State
- OH
- Country
- United States
- Event id
- 99704
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