BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Failure
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
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 involves a medical device that fails to meet sterility standards, creating a risk of infection (risk-of-harm product), but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets, Catalog no 367342. The recall is due to the products not meeting the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
The affected products were distributed in the United States, Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland, and Lithuania. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected blood collection sets and contact Becton Dickinson & Company for further instructions or a replacement.
The recalled product
- Product
- BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
- Manufacturer
- Becton Dickinson & Company
Distribution
Distributed nationwide across the United States.
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.
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