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Autosoft90™
Unomedical A/S · Model 1000282 · UDI-DI 05705244014572
FPA
Prescription
10
510(k) clearances
349,375
Adverse events (807 deaths)
1,085
Recalls
424
Facilities
Description
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the instruction for use.
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.