CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report
The BD Vacutainer Plus Plastic Citrate Blood Collection recalled
Becton Dickinson & is recalling The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood, distributed nationwide in the US. The recall was initiated on 11 Apr 2018 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-2260-2018
- FDA event ID
- 79901
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2018
- FDA classified
- 20 Jun 2018
- Reported
- 27 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Apr 2018 | Recall initiated by company | |
| 20 Jun 2018 | Classified by FDA | +70 days |
| 27 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
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
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.
Where it was distributed
US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
Nationwide ArkansasCaliforniaColoradoIndianaPennsylvaniaPuerto Rico
Questions about this recall
Is The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood recalled?
Yes. Becton Dickinson & recalled The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood on 11 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2260-2018.
Why was it recalled?
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
Which lots are affected?
All lots
Where was it sold?
US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
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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