BD Vacutainer Plus Plasma Separator Tubes Recalled for Deformed Reservoirs
Becton Dickinson is recalling BD Vacutainer Plus Plasma Separator Tubes due to deformed tube reservoirs reported in two customer complaints.
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 physical deformation reported in only two complaints with no mention of injury or illness.
Plain-English summary
Becton Dickinson & Company is conducting a recall of BD Vacutainer Plus Plastic Plasma Separator Tubes (PST) with Light Green/BD Homogard Closure. The recall is being conducted due to a deformed top of the tube reservoir reported in two customer complaints.
The affected products are used in hospitals, outpatient clinics, and physicians' offices to collect blood from patients for specialized chemistry testing. The recall covers 225 million units distributed nationwide. Specific reference numbers and tube sizes involved include Reference No. 367960 (13 X 75) and Reference Nos. 367961-367963, and 368035 (13 X 100), across all lots.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or replacement of these units.
The recalled product
- Product
- BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for…
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 225
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)
- Reference No.: 367960
- Tube Size: 13 X 75. Reference Nos. 367961-367963
- and 368035
- Tube Size: 13 X 100
- all lots
Distribution
Distributed nationwide across the United States.
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