Home › SPS Medical Supply Corp. › SPORVIEW STEAM BI TEST PACK-25 CNTRLS
SPORVIEW STEAM BI TEST PACK-25 CNTRLS
SPS Medical Supply Corp. · Model SBT-025 · UDI-DI 10732224720989
10
510(k) clearances
1,469
Adverse events
46
Recalls
42
Facilities
Description
Single use test pack designed to routinely challenge the steam sterilization process in both gravity and prevacuum steam sterilizers
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-08-31 | Steris Corporation | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2026-04-13 | HF Acquisition Co LLC | Due to incorrect incubation process being performed on product. |
| 2025-01-15 | TERRAGENE 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. |
| 2024-12-11 | HF Acquisition Co LLC | Spore 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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Get your free API keyRead the docsData 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.