HF Acquisition Co

4 recalls •

🏥 Medical Devices 💊 Drugs

• Categories: Diagnostic Equipment, Prescription Drugs

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

🏥 Medical Devices Class I - Dangerous

Due to incorrect incubation process being performed on product.

Apr 13, 2026 Diagnostic Equipment Nationwide View Details →

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

🏥 Medical Devices Class I - Dangerous

Due to incorrect incubation process being performed on product.

Apr 13, 2026 Diagnostic Equipment Nationwide View Details →

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

🏥 Medical Devices Class I - Dangerous

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.

Dec 11, 2024 Diagnostic Equipment Nationwide View Details →

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

💊 Drugs Class I - Dangerous

Labeling: Label Mix-up

Jun 6, 2023 Prescription Drugs View Details →

STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300

🏥 Medical Devices Class I - Dangerous

Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

Jun 4, 2020 Other Medical Devices Nationwide View Details →

STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300

🏥 Medical Devices Class I - Dangerous

Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

Jun 4, 2020 Other Medical Devices Nationwide View Details →

STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

🏥 Medical Devices Class I - Dangerous

Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

Jun 4, 2020 Other Medical Devices Nationwide View Details →

STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

🏥 Medical Devices Class I - Dangerous

A missing component (hand suction pump) in the emergency medical kits.

Jun 5, 2020 Infusion Pumps Nationwide View Details →

HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

🏥 Medical Devices Class I - Dangerous

Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

Jun 4, 2020 Other Medical Devices Nationwide View Details →

Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12

💊 Drugs Class I - Dangerous

TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

Jun 17, 2020 Prescription Drugs View Details →