BD Vacutainer Luer Adapter Recalled for Potential Blood Leakage and Low Draw Volume
Becton Dickinson is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapters due to potential blood leakage and low draw volume.
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 risk-of-harm product (blood leakage and low draw volume) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Becton Dickinson & Company is recalling the BD Vacutainer Multiple Sample and Direct Draw Luer Adapter. This sterile, non-invasive medical device is used to connect venous access devices, such as needles and blood collection sets, to blood collection tubes.
The recall was initiated because the devices may experience blood leakage and low draw volume. The affected units were distributed nationwide. The specific catalog numbers involved are 367290, 367300 (CE), 368491, and 303380.
Healthcare providers and facilities should stop using the affected devices and contact Becton Dickinson for further instructions on handling the recall.
The recalled product
- Product
- BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 37,906,400
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 (5)
- Marketing Status: Class II
- 510K # K991088 Device Listing Number: D030347 Catalog number 367290
- 367300 (CE)
- 368491
- and 303380.
Distribution
Distributed nationwide across the United States.
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