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CLIC

FLEXICARE MEDICAL LIMITED · Model 050-65-412U · UDI-DI 05055931112877

BSY Prescription

510(k) clearances

3,487

Adverse events (42 deaths)

Recalls

248

Facilities

Description

Adult ET Closed Suction Catheter Size 12Fr 540mm with Double Swivel Elbow and MDI Port

Recalls

Date	Firm	Reason
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2025-03-19	Avanos Medical, Inc.	Lack of sterility assurance for closed suction catheter systems
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-11-15	MEDLINE INDUSTRIES, LP - Northfield	Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile

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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.