Device 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 specialized chemistry testing.
Z-0911-2013
Product summary
- Event
- Event 64013
- Status
- Terminated
- Classification
- Class III
- Quantity
- 225 million units
- Official record key
device-enforcement:Z-0911-2013
Official wording
Reason: BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
Code information: Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.