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3M™ Attest™

3M COMPANY · Model 41360 · UDI-DI 30707387787241

FRCJOJ
10
510(k) clearances
1,469
Adverse events
46
Recalls
42
Facilities

Description

3M™ Attest™ Steam Chemical Integrator Test Pack, 41360, 4 PK/BG 4 BG/BX 4 BX/CS

Recalls

DateFirmReason
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-08-31Steris CorporationGeobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential
2026-04-13HF Acquisition Co LLCDue to incorrect incubation process being performed on product.
2026-04-13HF Acquisition Co LLCDue to incorrect incubation process being performed on product.
2025-01-15TERRAGENE S.A.Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
2024-12-11HF Acquisition Co LLCSpore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results t

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.