Food, drugs, devices › Becton Dickinson & Company
Device recall: BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Becton Dickinson & Company (Franklin Lakes, NJ) initiated this device recall on 12 Nov 2012; FDA lists 1 product record under event 64010, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 6 Sep 2013. Initiation: voluntary: firm initiated. Becton Dickinson & Company has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton Dickinson & Company, Franklin Lakes, NJ.
Reason for recall
"BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints."
Distribution
"Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0756-2013 | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL | 2,944,700 units | Class II | Terminated | 6 Feb 2013 |
Context
Other enforcement events for Becton Dickinson & Company
All 84 events for Becton Dickinson & Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Sep 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.