Recall Z-1141-2025

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.

FDA-determined cause: Error in labeling

Action taken

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.