CLASS III Device recall · Reported 13 Mar 2013 · FDA Enforcement Report
BD Vacutainer PST Gel and Lithium Heparin (LH) recalled
Becton Dickinson & is recalling BD Vacutainer PST Gel and Lithium Heparin (LH);; Plus Blood Collection Tubes, distributed nationwide in the US. The recall was initiated on 5 Mar 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0911-2013
- FDA event ID
- 64013
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Mar 2012
- FDA classified
- 6 Mar 2013
- Reported
- 13 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 5 Mar 2012 | Recall initiated by company | |
| 6 Mar 2013 | Classified by FDA | +366 days |
| 13 Mar 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is BD Vacutainer PST Gel and Lithium Heparin (LH);; Plus Blood Collection Tubes recalled?
Yes. Becton Dickinson & recalled BD Vacutainer PST Gel and Lithium Heparin (LH);; Plus Blood Collection Tubes on 5 Mar 2012. The recall is Class III and its status is Terminated. Recall number Z-0911-2013.
Why was it 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.
Which lots are affected?
Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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