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Quick-set® Paradigm®

Unomedical A/S · Model MMT-396 · UDI-DI 05705244006799

FPA Prescription

510(k) clearances

349,375

Adverse events (807 deaths)

1,089

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
2026-08-19	BD SWITZERLAND SARL	Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
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.
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
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

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Data 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.