Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1056-2013·Announced 2013-04-10

BD Vacutainer Urinalysis Transfer Straw Kit Recalled for Mislabeling

Becton Dickinson is recalling BD Vacutainer Urinalysis Transfer Straw Kits due to incorrect polybag labeling that may cause users to mistake the tube for a culture and sensitivity tube.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which by definition is unlikely to cause adverse health consequences. The hazard is a labeling error that could lead to the use of a medical device for an unintended purpose, fitting the criteria for a moderate severity recall involving minor labeling errors.

Plain-English summary

Becton Dickinson & Company is recalling the BD Vacutainer Urinalysis Transfer Straw Kit, Catalog #364991, Lot 1335484. The recall involves 236,400 units that were distributed nationwide, including to customers in Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.

The recall was initiated because the preprinted polybags for the kits are incorrectly labeled as Catalog #364953. The source text notes that the tube included in the recalled kit is not a culture and sensitivity (C&S) tube. If a customer relies solely on the polybag labeling and uses the tube for collecting urine for culture and sensitivity testing, it is possible for the tube to be used for an unintended purpose.

Customers who purchased this specific kit should verify the catalog number on the polybag. If the polybag is labeled as Catalog #364953 but the product is the Urinalysis Transfer Straw Kit #364991, the tube should not be used for culture and sensitivity testing.

The recalled product

Product: BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Urine Collection
Hazard: mis-labeling
Affected units: 236,400

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)

Catalog #3694991 appears as Catalog #364953 (Lot #1335484)

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · Becton Dickinson & Company

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