Recall Z-1141-2025— HF Acquisition Co LLC
Class II · Ongoing
Class II FDA medical device recall by HF Acquisition Co LLC, initiated 2024-12-11. It names 3 FDA 510(k) clearances: K041099, K023716, K905425. Product: Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580. Reason: 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 to be reported to the incorrect customer's account..
- Recalling firm
- HF Acquisition Co LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-11
- Firm location
- Mukilteo, WA, United States
510(k) clearances named in this recall
3 on FDA's record- K041099 — MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
- K023716 — SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
- K905425 — SPORVIEW
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Reason for recall
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 to be reported to the incorrect customer's account.
Data sourced from openFDA. This site is unofficial and independent of the FDA.