| | Class 2 Device Recall Biological, BIO12 HealthFirst Mail In Monitoring System |  |
| Date Initiated by Firm | December 11, 2024 |
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| Date Posted | February 11, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1141-2025 |
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| Recall Event ID |
96042 |
| 510(K)Number | K023716 K041099 K905425 |
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| Product Classification |
Indicator, biological sterilization process - Product Code FRC
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| Product | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.
Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 |
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| Code Information |
Item/UDI-DI/Lot(Expiration):
1003600/10850065007820/
2301060(11/30/2024)
2302261(11/30/2024)
2307261(12/31/2024
2312260(1/31/2025)
2313062(1/31/2025)
2331880(6/30/2025)
2401664(8/31/2025)
2414060(2/28/2026)
2414862(3/31/2026)
2414870(3/31/2026)
2416470(3/31/2026)
2416481(4/30/2026)
2416482(4/30/2026)
1003580/10850065007813/2421181(5/31/2026) |
| FEI Number |
3014534
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Recalling Firm/
Manufacturer |
HF Acquisition Co LLC
11629 49th Pl W
Mukilteo
WA
98275-4255
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| For Additional Information Contact |
800-331-1984 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | 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. |
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| Quantity in Commerce | 4,021 |
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| Distribution | 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
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FRC
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