Z-1141-2025Class II

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12...

Name: Z-1141-2025 Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12...
Creator: HF Acquisition Co LLC
Published: 2024-12-11
License: https://open.fda.gov/license/

HF Acquisition Co. LLC / initiated 2024-12-11 / Open, Classified / root cause: labeling and UDI

FDA source

HF Acquisition Co LLC began a recall of Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item... on 2024-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1141-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-11
Posted: 2025-02-11
Recalling firm: HF Acquisition Co. LLC
Product: Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Product code: FRC Indicator, Biological Sterilization Process
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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 [email protected] Should you have any questions about this urgent field correction, please contact Customer Service at 855-476-1342 or email us at [email protected].
Quantity in commerce: 4,021
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
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1141-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

Product code FRC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)