Z-0499-2020Class II

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547

Name: Z-0499-2020 BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Creator: Becton Dickinson & Company
Published: 2019-10-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-10-14 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 on 2019-10-14. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0499-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Posted: 2019-11-20
Terminated: 2020-10-16
Recalling firm: Becton Dickinson & Co
Product: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Product code: NGT Saline, Vascular Access Flush
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 1,632,000
Distribution: Distribution US Nationwide and Canada
Product codes and lots: Lot Number: 9142881 UDI: 50382903065474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0499-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0499-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-20
Z-0500-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-20

Product code NGT

K161552Class II0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company / cleared 2017-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)