CLASS I Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

BD Vacutainer¿ EDTA Lavender Top Tubes recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Vacutainer¿ EDTA Lavender Top Tubes, distributed in 47 states. The recall was initiated on 22 Mar 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll 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)

Quantity recalled1,116,012,050

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1139-2018
FDA event ID: 79223
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class I
Status: Terminated
Recall initiated: 22 Mar 2018
FDA classified: 22 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

22 Mar 2018	Recall initiated by company
22 Mar 2018	Classified by FDA	+0 days
28 Mar 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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)

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Is BD Vacutainer¿ EDTA Lavender Top Tubes recalled?

Yes. Becton Dickinson & recalled BD Vacutainer¿ EDTA Lavender Top Tubes on 22 Mar 2018. The recall is Class I and its status is Terminated. Recall number Z-1139-2018.

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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