Agency classClass IIOur severity:High FDA (Devices)·Z-1180-2018·Announced 2018-04-04

BD Vacutainer Blood Collection Tubes Recalled for Residual Blood on Stopper

Becton Dickinson is recalling 1,976,000 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes because increased residual blood was found on the top of the stopper well after venipuncture.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall, and the defect involves a risk-of-harm product (blood collection tubes) where the specific injury has not yet been reported in the source text.

Plain-English summary

Becton Dickinson & Company is recalling 1,976,000 units of BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes for in vitro diagnostic use. The affected catalog numbers are 365043, 365044, 365045, and 365047. These tubes are used to collect, separate, process, transport, and store venous blood samples for chemistry determinations, therapeutic drug monitoring, and zinc testing in plasma.

The recall was initiated because an increased amount of residual blood was present on the top of the stopper well after venipuncture. The affected units have expiration dates ranging from November 30, 2017, to July 31, 2018, and include UDI numbers 50382903650434, 50382903650441, 50382903650458, and 50382903650472.

The products were distributed nationwide in the United States. The FDA has classified this as a Class II recall. Healthcare facilities and laboratories should stop using the affected tubes and contact Becton Dickinson for further instructions.

The recalled product

Product: BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection Tubes
Hazard: contamination
quality-defect
Affected units: 1,976,000

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 (3)

All Lot Numbers Expiration Dates: November 30
2017 - July 31
2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472

Distribution

Distributed nationwide across the United States.

Same manufacturer · Becton Dickinson & Company

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