Z-0736-2024Class II

PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill)...

Name: Z-0736-2024 PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill)...
Creator: Becton Dickinson & Company
Published: 2023-11-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-11-16 / Open, Classified

FDA source

Becton Dickinson & Company began a recall of PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547 on 2023-11-16. FDA classified it as Class II and gives the reason as "An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0736-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-16
Posted: 2024-01-17
Recalling firm: Becton Dickinson & Co
Product: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Product code: NGT Saline, Vascular Access Flush
Reason for recall: An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.
FDA root cause: Under Investigation by firm
Action: An URGENT: Medical Device Product Advisory dated 11/16/23 was sent to customers. Please Take the Following Actions: 1. Immediately review your inventory for the affected product. a. If the product is used for syringe pumps, destroy all affected product subject to this field action following your institution's process for destruction. b. If the product is used for manual application, the product can continue to be used per IFU. 2. If the affected product was previously used on a patient, no further actions are needed. 3. If the affected product is currently in use with a syringe pump, replace the syringe with a non-impacted lot. Please note that healthcare facilities and providers should rely on their syringe pump manufacturer's IFU for the specific syringes that are compatible with their syringe pumps. 4. Share this field action notification with all users of the product within your facility network to ensure they are also aware of this field action. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement if product is used on syringe pumps and has been discarded. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA 1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Distributors Please Take the Following Actions: 1. Immediately review your inventory for the affected product. Destroy all unused product subject to the product advisory following your institution s process for destruction. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide
Quantity in commerce: 5,085,120 units
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX,UT, VA, WA, WI, WV.
Product codes and lots: UDI-DI: 30382903065470; Lot Numbers: 3207548 3207555 3214826 3226386 3214828 3226388 3250302 3250303 3250304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)