Alaris, SmartSite recallZ-1944-2024 · Bd Switzerland Sarl · initiated Apr 18, 2024
Class II Open, Classified All recalls posted in May 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Switzerland Sarl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1944-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 18, 2024
- Posted by the FDA
- May 31, 2024
- Recalling firm
- Bd Switzerland Sarl
- Quantity
- 11.300 sets
- Product code
- FPA
- FDA submissions
- K022209
- 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 description
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 (models, lots, serial numbers)
Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alaris, SmartSite 10013072BD Switzerland Sàrl · Set, administration, intravascular3 recalls33 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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