SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model...
FDA Device Recall #Z-0372-2026 — Class II — May 5, 2025
Recall Summary
| Recall Number | Z-0372-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 5, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Location | Austell, GA |
| Product Type | Devices |
| Quantity | 4,272,858 |
Product Description
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910
Reason for Recall
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI and the country of CA.
Lot / Code Information
Model/UDI-DI/Lots: 07 6011/10643351000014/23H4110, 23I4017, 23I4051, 23J4031, 23K4058, 23K4059, 23L4082, 24A4103, 24B4186, 24B4187, 24D4015, 24E4138, 24E4139, 24H4121, 24I4317, 24I4328, 24J4041, 24J4137, 24J4138, 24J4233, 24J4316, 24J4348; 07 6013/10643351000021/23H4111, 23I4018, 24B4188, 24H4125, 25B4099; 07 7051/10643351000038/23H4157, 23I4020, 23I4374, 23J4033, 23K4060, 23L4083, 24A4104, 24B4190, 24D4016, 24E4140, 24F4053, 24I4321, 24J4043, 24J4139, 24J4237, 24L4001, 25B4107; 07 7052/10643351000045/23H4113, 23I4021, 23J4034, 24A4105, 24D4017, 24F4052, 24H4126, 24I4323, 24J4042, 24J4140, 24J4338, 24J4355, 25B4108; 07 7053/10643351000052/23I4022, 23J4035, 23L4084, 24D4018, 24E4132, 24F4192, 25B4106; 07 7056/10643351000069/24A4106, 24B4191, 24B4192, 24E4133, 24I4315, 24J4136, 24J4347; 07 7058/10643351000076/23G4430, 23G4168. Manufactured between July 31, 2023 and February 28, 2025.
Other Recalls from ASP Global, LLC. dba Anatomy Supply P...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0564-2026 | Class II | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas ... | Sep 26, 2025 |
| Z-0545-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection, 2... | Sep 26, 2025 |
| Z-0544-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection, 1... | Sep 26, 2025 |
| Z-0556-2026 | Class II | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50... | Sep 26, 2025 |
| Z-0547-2026 | Class II | SAFE-T-FILL Micro Capillary Blood Collection, 2... | Sep 26, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.