CLASS II Device recall · Reported 6 Jan 2016 · FDA Enforcement Report
BD Vacutainer PLUS K2EDTA Tubes (Plastic) recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Vacutainer PLUS K2EDTA Tubes (Plastic), distributed nationwide in the US. The recall was initiated on 3 Dec 2015 and the FDA has classified it as Class II.
Check your package
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-0571-2016
- FDA event ID
- 72868
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2015
- FDA classified
- 31 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2015 | Recall initiated by company | |
| 31 Dec 2015 | Classified by FDA | +28 days |
| 6 Jan 2016 | 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
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
Where it was distributed
Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
Questions about this recall
Is BD Vacutainer PLUS K2EDTA Tubes (Plastic) recalled?
Yes. Becton Dickinson & recalled BD Vacutainer PLUS K2EDTA Tubes (Plastic) on 3 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0571-2016.
Why was it recalled?
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Which lots are affected?
Catalog Reference #367844; Lot number 5154624 Catalog Reference #367862; Lot numbers 5089771 and 5187753 Catalog Reference #368021; Lot number 5089820
Where was it sold?
Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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