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Alaris, SmartSite
BD Switzerland Sàrl · Model 2438-0500 · UDI-DI 10885403274114
FPA
Prescription
10
510(k) clearances
309,975
Adverse events (779 deaths)
1,085
Recalls
424
Facilities
Description
Pump Infusion Set, Back Check Valve, 4-Way Stopcocks, 4 Y-Sites 326 cm (128 in)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | B Braun Medical Inc | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. |
| 2026-06-30 | Baxter Healthcare Corporation | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. |
| 2026-06-16 | BD SWITZERLAND SARL | Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterili |
| 2026-06-05 | Medela Inc | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritiona |
| 2026-06-04 | BD SWITZERLAND SARL | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. |
| 2026-02-17 | Molded Products Inc | Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and |
| 2025-12-31 | Medline Industries, LP | Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crac |
| 2025-12-19 | ICU Medical, Inc. | Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.