The Recall Desk
LowFDA (Devices)·Z-0911-2013·Announced 2013-03-13

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.

What this means for you

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 speci
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.