BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 3664...

FDA Device Recall #Z-1139-2018 — Class I — March 22, 2018

Recall Summary

Recall Number Z-1139-2018
Classification Class I — Serious risk
Date Initiated March 22, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Company
Location Franklin Lakes, NJ
Product Type Devices
Quantity 1,116,012,050

Product Description

BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

Reason for Recall

BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.

Distribution Pattern

Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.

Lot / Code Information

All lots. Catalog Number (Shelf Life): 1. 366401 (24 months); 2. 366450 (24 months); 3. 366643 (12 months); 4. 367835 (16 months); 5. 367841 (15 months); 6. 367844 (16 months); 7. 367856 (16 months); 8. 367861 (16 months); 9. 367862 (16 months); 10. 367863 (17 months); 11. 368021 (16 months); 12. 368047 (15 months); 13. 368054 (16 months); 14. 368661 (17 months); 15. 364300 (Requested)

Other Recalls from Becton Dickinson & Company

Recall # Classification Product Date
Z-1496-2026 Class II 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... Jan 27, 2026
Z-0504-2026 Class II BD Luer Tip Caps; Catalog Number(s) or Model N... Oct 14, 2025
Z-0736-2024 Class II PosiFlush Prefilled Saline Syringe with General... Nov 16, 2023
Z-0349-2024 Class II BD Alaris Pump infusion sets (Product Name, Cat... Oct 11, 2023
Z-0351-2024 Class II BD Extension Sets (Product Name, Catalog #) ... Oct 11, 2023

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.