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FDA Devices Verify with FDA Devices → Moderate Class II Terminated

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

Reported: February 22, 2017 Initiated: January 16, 2017 #Z-1189-2017 1,488,800 tubes units

Becton Dickinson & Company issued this FDA Devices recall on February 22, 2017. Classified as Moderate severity (Class II). Approximately 1,488,800 tubes units are affected. The recall was issued because: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffer…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-1189-2017) was formally reported on February 22, 2017, with the manufacturer initiating the action on January 16, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records indicate 1,488,800 tubes units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

1,488,800 tubes

Related Recalls

6

6 from same agency

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.

Details

Units Affected
1,488,800 tubes
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
Location
Franklin Lakes, NJ

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
Units affected 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.

Scale of Impact

1,488,800 tubes units affected — million-unit bracket.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1189-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).