BD PosiFlush recallZ-0499-2020 · Becton Dickinson & Company · initiated Oct 14, 2019
Terminated
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
Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
FDA root cause category: Packaging process control
What the company is doing
BD issued notifications to Customers via FedEx to Distributors, Pharmacies, and Consumers via Pharmacies on 10/14/19, advising of the problem, health risk and action to take: Immediately review your inventory for the specific Catalog and Lot number listed , discontinue use and destroy all product subject to the recall following your institutions process for destruction.2. Complete the Customer Recall Response Form. Questions or require further assistance, please contact 1-888-731-7973 between 8 AM and 5 PM ET Monday through Friday.
Recall details
- Recall number
- Z-0499-2020
- Status
- Terminated
- Initiated by the company
- Oct 14, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 1,632,000
- Product code
- NGT
- FDA submissions
- K161552
- Distribution
- Distribution US Nationwide and Canada
Product description
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Code information (models, lots, serial numbers)
Lot Number: 9142881 UDI: 50382903065474
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K161552 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD PosiFlush™ 306499Becton, Dickinson And Company · Saline, vascular access flush45 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84113).
- Z-0500-2020 · TerminatedBD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
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 16, 2026. Text above is shown as published by the FDA.
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