BD Vacutainer PST Gel and Lithium Heparin (LH) recallZ-0911-2013 · Becton Dickinson & Company · initiated Mar 5, 2012
Class III Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Equipment maintenance
What the company is doing
BD sent advisory letters via UPS dated 3/5/2012 to customers. The letter identified the affected product and the reason for recall. BD has taken steps to modify the existing manufacturing and assembly processes to help reduce the potential for this condition. Questions regarding this issue should be directed to BD Global Technical Services at 1-800-631-0174 or email at www.bd.com/Vascutainer/contact.
Recall details
- Recall number
- Z-0911-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Mar 5, 2012
- Posted by the FDA
- Mar 6, 2013
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 225 million units
- Product code
- JKA
- FDA submissions
- K945952
- Distribution
- Nationwide Distribution
Product 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.
Code information (models, lots, serial numbers)
Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Other devices under the same FDA submission
1 device cleared under K945952 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Vacutainer® Buff. Na Citrate (9NC) 369714Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall159 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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