HF Acquisition Co LLC recalls Biological

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.

On 12/11/2024, correction notices were mailed to customers asking them to do the following: 1. Check the box number on your Biological Weekly Monitoring kit for the affected lot numbers. The box number is located under the bar code on the outside of the box (see image below). 3. Check the serial number on all test strip return envelopes located in the box. This number is the last set of digits in the alphanumeric string located to the left of the bar code on the envelope. 4. Verify that the box number matches the last three digits of the serial number on the return envelope. 5. If the numbers do not match, you are hereby instructed to isolate your inventory of the above-listed lot numbers and dispose of it in regular trash. Firm will work with you on replacement product. 6. Ensure this letter is promptly brought to the attention of those responsible for managing the medical device inventory. Distribute this notification to all device users within your facility and network to ensure they are informed of this field correction letter. Please share this notification with any organizations that have received the potentially affected devices. 7. Complete and return the response form via email to quality@healthfirst.com Should you have any questions about this urgent field correction, please contact Customer Service at 855-476-1342 or email us at customerservice@healthfirst.com.

• FDA enforcement recordOfficial FDA database entry for Z-1141-2025
• FDA 510(k) clearance · K023716The device's official FDA premarket clearance record
• FDA 510(k) clearance · K041099The device's official FDA premarket clearance record
• FDA 510(k) clearance · K905425The device's official FDA premarket clearance record
• FDA device classification · FRCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.2800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find HF Acquisition Co LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.