BD Vacutainer SST Plus Blood Collection Tubes Recalled for Stopper Defects
Becton Dickinson & Company is recalling specific lots of BD Vacutainer SST Plus Blood Collection Tubes because some stoppers were manufactured with a reduced cycle cure time.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which the rubric defines as unlikely to cause adverse health consequences. The defect is a manufacturing specification issue with no reported injuries or illnesses.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. The affected products are identified by REF #367986 and Lot #5133957 (243,000 units) and Lot #5133959 (238,000 units). These tubes are used to collect, transport, separate, and process blood in a closed system.
The recall was initiated because some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Specifically, the stoppers were manufactured with a reduced cycle cure time.
The affected products were distributed in Florida, Illinois, Massachusetts, Michigan, Missouri, Pennsylvania, and Tennessee. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
- Manufacturer
- Becton Dickinson & Company
- Hazard
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 (2)
- REF #367986
- Lot #'s 5133957 and 5133959
Distribution
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