CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report
BD Vacutainer Buffered Sodium Citrate recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube x mm), distributed nationwide in the US. The recall was initiated on 16 Jan 2017 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-1189-2017
- FDA event ID
- 76295
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2017
- FDA classified
- 10 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Jan 2017 | Recall initiated by company | |
| 10 Feb 2017 | Classified by FDA | +25 days |
| 22 Feb 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
Questions about this recall
Is BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube x mm) recalled?
Yes. Becton Dickinson & recalled BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube x mm) on 16 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1189-2017.
Why was it recalled?
A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
Which lots are affected?
Lot 6090572
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
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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