Agency classClass IIOur severity:High FDA (Devices)·Z-2710-2016·Announced 2016-09-07

BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation

Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.

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 recall is classified as FDA Class II and involves a structural defect in a medical device that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Becton Dickinson & Company is recalling 1,788,150 units of BD Vacutainer Push Button Blood Collection Sets, Sterile, Rx only, REF 367342. The affected lots are 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634, and 6006650. These products were distributed in the US and internationally.

The recall was initiated due to reports that specific lots exhibit separation of the front and rear barrels upon activation of the safety feature, which retracts the needle. This defect is classified as an FDA Class II recall.

Healthcare providers and patients should stop using the affected lots immediately. The source text does not specify a particular consumer action beyond the recall notice, but users should verify lot numbers against the list provided and contact the manufacturer or their supplier for instructions on replacement or return.

The recalled product

Product: BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection
Hazard: structural-defect
needle-injury
Affected units: 1,788,150

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 (9)

Lot number: 5355531
5355533
5356681
5356682
6006629
6006630
6006631
6006633
6006634 and 6006650.

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Becton Dickinson & Company

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