The Recall Desk
HighFDA (Devices)·Z-0193-2020·Announced 2019-10-30

BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation

Becton Dickinson is recalling 1.7 million BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the needle retracts.

What this means for you

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 the defect presents a risk of harm (needle exposure or injury) without reported illnesses or injuries in the source text, meeting the criteria for a High severity score.

Plain-English summary

Becton Dickinson & Company is recalling approximately 1,735,600 units of the BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder, catalog number 368356. The recall is due to a defect where the front and rear barrels of the device may separate upon activation of the safety feature that retracts the needle.

The affected products were distributed worldwide, including nationwide distribution in the United States and in specific countries such as Trinidad and Tobago and Hong Kong. The recall covers specific lot numbers, including 9079767, 9079770, 9081829, 9086811, 9086812, 9091607, 9091626, 9094659, 9094661, 9098547, 9100711, 9100712, 9115965, and 9115913.

Healthcare facilities and users should stop using the affected blood collection sets and contact Becton Dickinson for instructions on how to return the products or obtain a replacement.

The recalled product

Product
BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. F
Affected units
1,735,600

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically: