Food, drugs, devices › Becton Dickinson & Company
Device recall: BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for t
FDA enforcement event 69047 is a device recall by Becton Dickinson & Company of Franklin Lakes, NJ, initiated 22 Jul 2014 and classified Class II, with 1 product record.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Apr 2015. 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 received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553)."
Distribution
"Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2673-2014 | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps. | 3,088,320 units | Class II | Terminated | 1 Oct 2014 |
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 received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553)."
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: "Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Apr 2015. "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.