Z-2673-2014Class II

BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used...

Name: Z-2673-2014 BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used...
Creator: Becton Dickinson & Company
Published: 2014-07-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of 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... on 2014-07-22. FDA classified it as Class II and gives the reason as "BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553)". 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-2673-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-09-22
Terminated: 2015-04-21
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
Root cause tag: packaging
FDA root cause: Packaging
Action: BD sent recall letters/recall response cards dated 7/22/2014 via e-mail or UPS 2nd day mail. Customers are asked to examine their inventory and quarantine any affected product subject to recall. Customers should complete the Recall Response Card and fax it back to BD at 1-201-847-6990. Any questions can be directed to 1-888-237-2762 option 3.
Quantity in commerce: 3,088,320 units
Distribution: Nationwide Distribution.
Product codes and lots: REF #306553 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2673-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2673-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code NGT

K121050Class II0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush SyringeBecton, Dickinson & CO / cleared 2013-02-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)