Z-1944-2024Class II

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

Name: Z-1944-2024 Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072...
Creator: Bd Switzerland Sarl
Published: 2024-04-18
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2024-04-18 / Open, Classified / root cause: manufacturing process

FDA source

BD SWITZERLAND SARL began a recall of 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... on 2024-04-18. FDA classified it as Class II and gives the reason as "Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1944-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-05-31
Recalling firm: BD Switzerland SARL
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root 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: [email protected] for Product Complaints or Technical Questions. Field Actions/Recalls - Email:[email protected] 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.
Product codes and lots: Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31

Product code FPA

K022209Class IIAlaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc. / cleared 2002-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)