Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2260-2018·Announced 2018-06-27

BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Becton Dickinson & Company is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) with light blue tops. The recall is due to a defect where approximately 3.4% of the tubes exhibit overfill draw volumes ranging from approximately 11% to 14%.

The affected product is an evacuated blood collection tube used to collect, transport, and process blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen used for clinical laboratory coagulation assays. The recall covers all lots of the product.

The product was distributed to all 50 U.S. states, Puerto Rico, and various international locations including Argentina, Bolivia, Brazil, and others. Distribution dates range from June 2, 2017, to the present. Consumers and healthcare facilities should stop using the affected tubes and contact the manufacturer for further instructions.

The recalled product

Product: 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…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection Tubes
Hazard: overfill
volume-accuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Becton Dickinson & Company

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Same hazard · overfill