Class 2 Device Recall BD PosiFlush Prefilled Saline Syringe

• Date Initiated by Firm: November 16, 2023
• Date Posted: January 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0736-2024
• Recall Event ID: 93562
• 510(K)Number: K161552
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
• Code Information: UDI-DI: 30382903065470; Lot Numbers: 3207548 3207555 3214826 3226386 3214828 3226388 3250302 3250303 3250304
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NGT