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ModerateClass IITerminated

FDA Devices recall · Reported February 22, 2017

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

A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.

Recall #
Z-1189-2017
Affected scope
1,488,800 tubes
Initiated
January 16, 2017
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Becton Dickinson & Company recalled BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm)… - a moderate-severity action.

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm)… was recalled by Becton Dickinson & Company in February 22, 2017. Reason: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount…. Check the official notice for the remedy. Verify recall #Z-1189-2017 with the FDA Devices before acting.

The recall

Becton Dickinson & Company issued this moderate-severity FDA Devices recall-A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount….

Moderate
severity level
Class II
classification
February 22, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1189-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1189-2017
Date reported February 22, 2017
Date initiated January 16, 2017
Recalling firm Becton Dickinson & Company
Firm location Franklin Lakes, NJ
Affected scope 1,488,800 tubes
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1189-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Becton Dickinson & Company. Units affected: 1,488,800 tubes.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1189-2017.
Where was the recalled product distributed?
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 22, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026