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Custom Medical Specialties, Inc.

CUSTOM ASSEMBLIES, INC. · Model CMS-1214 · UDI-DI 00815849021129

FPA

510(k) clearances

368,059

Adverse events (818 deaths)

1,090

Recalls

424

Facilities

Description

Double Spike Tumescent Set - Sterile

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	Products may not have received adequate sterilization processing.
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

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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.