Becton Dickinson Recalls BD Microtainer SST Tubes Due to Damaged Reservoirs
Becton Dickinson is recalling BD Microtainer SST tubes because damaged reservoirs may cause insufficient sample volume and erroneous test results.
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 the hazard involves a risk of harm (erroneous test results) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling BD Microtainer SST tubes, Part/Catalog No. 365967. The recall is due to a defect where the damaged reservoir may lead to a decreased fill volume.
This defect can cause samples to be insufficient for testing and result in an improper blood-to-additive ratio, potentially producing erroneous results. The affected products were distributed nationwide and in various foreign countries.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the official recall notice and stop using the affected products. Users should contact Becton Dickinson for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- BD Microtainer SST Part/Catalog No.365967
- Manufacturer
- Becton Dickinson & Company
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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