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.

This recall is currently active, issued May 31, 2024.

Recall Initiated: April 18, 2024
Posted: May 31, 2024
Recall Number: Z-1944-2024
Quantity: 11.300 sets
Official Source: View on FDA website ↗

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.

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.

Lot / Code Info

Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

Root Cause

Process control

Action Taken

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.