Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used

FDA device recall Z-1944-2024 · posted 2024-05-31 · Open, Classified

Recall details

Recalling firm

BD SWITZERLAND SARL

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.

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.

Root cause

Process control

Status

Open, Classified

Product code

FPA

Quantity affected

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.

Date initiated

2024-04-18

Date posted

2024-05-31

Location

Eysins, Switzerland

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