FDA Enforcement
Class III
Terminated
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.
Recall: Z-0911-2013
·
Reported March 13, 2013
Enforcement
- Recall Number
- Z-0911-2013
- Event ID
- 64013
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2013
- Initiation Date
- March 5, 2012
- Classification Date
- March 6, 2013
- Termination Date
- July 20, 2015
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
Description
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.
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 Info
Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Distribution
Nationwide Distribution
Quantity
225 million units