Home › B. BRAUN MEDICAL INC. › Infusomat®

Infusomat®

B. BRAUN MEDICAL INC. · Model 490038 · UDI-DI 04046964185946

FPA Prescription

510(k) clearances

368,061

Adverse events (819 deaths)

1,090

Recalls

426

Facilities

Description

60 drops/mL, priming volume: 11mL, length: 129in

Recalls

Date	Firm	Reason
2026-09-14	B Braun Medical Inc	Potential for leakage and backflow at the Safsite valve.
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.