CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report

Alaris Pump Infusion Set Low Sorbing Tubing recalled

BD Switzerland Sarl is recalling Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y, distributed nationwide in the US. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

Quantity recalled11.300 sets

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1944-2024
FDA event ID: 94479
Recalling firm: BD Switzerland Sarl, Eysins, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 18 Apr 2024
FDA classified: 31 May 2024
Reported: 12 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

18 Apr 2024	Recall initiated by company
31 May 2024	Classified by FDA	+43 days
12 Jun 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Colorado Illinois Kansas Massachusetts Maine New Jersey New York Pennsylvania South Dakota Washington Wisconsin

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from BD Switzerland Sarl

All 15

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
19 Aug 2026Device	CLASS II	Non-DEHP Minibore Extension Set RES ME2010 recalled	BD Switzerland Sarl	Sterility	26 states
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL
24 Jun 2026Device	CLASS II	BD Connecta" BD Luer-Lok" recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Foreign Material	39 states
3 Sep 2025Device	CLASS II	BD PhaSeal Injector Luer (N30C) recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Packaging Defects	Nationwide

Other Infusion Pumps recalls

All 549

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide