Class 2 Device Recall Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites

• Date Initiated by Firm: April 18, 2024
• Date Posted: May 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1944-2024
• Recall Event ID: 94479
• 510(K)Number: K022209
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
• Code Information: Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
• Recalling Firm/ Manufacturer: BD SWITZERLAND SARL; Terre Bonne Park A4; Route De Crassier 17; Eysins Switzerland
• For Additional Information Contact: Laura Corrado; 267-810-4653
• Manufacturer Reason for Recall: Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
• FDA Determined Cause: Process control
• Action: On 04/18/2024, the firm sent an URGENT: MEDICAL DEVICE PRODUCT RECALL" Letter via FedEx Express Saver to customer informing them that BD has received customer reports of the Alaris" Pump Infusion Set Low Sorbing Tubing (PE Lined) drip chamber becoming detached from the tubing for the catalog number and lot number referenced above. BD has confirmed that this issue is isolated to catalog number, 10013072 only and a single lot (no. 22115368) where mis-assembly of the drip chamber to the tubing occurred. Customers are instructed to: 1. Ensure the contents of this Product Recall communication are read and understood by those within their organization. 2. Immediately review their inventory for Catalog Number 10013072, Lot number 22115368. Destroy all unused product subject to the recall following their institution s process for destruction. 3. Notify all entities of this recall to whom the affected product may have been transferred. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form, whether or not they have any of the impacted material, so that BD may acknowledge your receipt of this notification and process their request for replacement product. For questions or assistance - contact: North American Regional Complaint Center - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com for Product Complaints or Technical Questions. Field Actions/Recalls - Email:BDRC18@BD.com for Recall related questions.
• Quantity in Commerce: 11.300 sets
• Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.
• 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 = FPA