Food, drugs, devices › Becton Dickinson & Company
Device recall: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Becton Dickinson & Company (Franklin Lakes, NJ) initiated this device recall on 14 Oct 2019; FDA lists 2 product records under event 84113, 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 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 16 Oct 2020. 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
"Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes."
Distribution
"Distribution US Nationwide and Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0499-2020 | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 | 1,632,000 | Class II | Terminated | 27 Nov 2019 |
| Z-0500-2020 | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only) | 967,680 | Class II | Terminated | 27 Nov 2019 |
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: "Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes."
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: "Distribution US Nationwide and Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Oct 2020. "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.