HF Acquisition Co LLC: Device Recall
Recall #Z-1141-2025 · 12/11/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1141-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- HF Acquisition Co LLC
- Status
- Ongoing
- Date Initiated
- 12/11/2024
- Location
- Mukilteo, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,021
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.
Product Description
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Distribution Pattern
US: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN, KS, SC, RI, LA, GA, PA, NH, UT, VA, MA, NV, MO, IL, SD, AR, OR, HI, NE, DC, CT, NM, ND, MT, OK, AL, VT, WY, KY, ME, IA, WV, AK
Other Recalls by HF Acquisition Co LLC
- Class III: Low Risk 06/06/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.