Severity
Moderate
FDA Devices recall · Reported June 12, 2024
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Bd Switzerland Sarl recalled Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sit… - a moderate-severity action.
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sit… was recalled by Bd Switzerland Sarl in June 12, 2024. Reason: Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treat…. Check the official notice for the remedy. Verify recall #Z-1944-2024 with the FDA Devices before acting.
The recall
Bd Switzerland Sarl issued this moderate-severity FDA Devices recall-Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treat….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1944-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1944-2024) was formally reported on June 12, 2024, with the manufacturer initiating the action on April 18, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Bd Switzerland Sarl is listed as the recalling firm, operating out of Eysins, N/A. Federal records list the affected scope as 11.300 sets.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
11.300 sets
Related Recalls
6
3 from same agency
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.
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1944-2024 |
| Date reported | June 12, 2024 |
| Date initiated | April 18, 2024 |
| Recalling firm | Bd Switzerland Sarl |
| Firm location | Eysins, N/A |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 12, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.