BD PosiFlush recallZ-0736-2024 · Becton Dickinson & Company · initiated Nov 16, 2023

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number

Z-0736-2024

Status

Open, Classified

Initiated by the company

Nov 16, 2023

Posted by the FDA

Jan 17, 2024

Recalling firm

Becton Dickinson & Company

Quantity

5,085,120 units

Product code

NGT

FDA submissions

K161552

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 description

PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD PosiFlush 306547

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 death331 reports

Product lines

• BD PosiFlushBecton, Dickinson And Company · 19 models · 1,187 reports · 2 recalls

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™ 306499

  Becton, Dickinson And Company · Saline, vascular access flush
  45 reports