BD Vacutainer Blood Collection Set Recalled for Sterility Assurance Failure
Becton Dickinson is recalling BD Vacutainer Ultra Touch 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 failed to meet sterility assurance standards, posing a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling the BD Vacutainer Ultra Touch Push Button Blood Collection Set, catalog number 367364. The recall involves a specific lot identified by code 7348980.
The product is being recalled because it does not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. This means the manufacturing process did not guarantee the required level of sterility for the medical device.
The affected products were distributed in the United States (nationwide), Canada, Kuwait, Guyana, Guatemala, Taiwan, the United Kingdom, Belgium, Sweden, Ireland, Israel, Spain, Switzerland, and Lithuania. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
- Manufacturer
- Becton Dickinson & Company
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)
- 7348980
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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