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CLIC

FLEXICARE MEDICAL LIMITED · Model 050-64-114U · UDI-DI 05055931112754

BSY Prescription
10
510(k) clearances
3,474
Adverse events (42 deaths)
89
Recalls
248
Facilities

Description

Adult ET Closed Suction Catheter Size 14Fr 540mm (21.3") with Double Swivel Elbow

Recalls

DateFirmReason
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2025-03-19Avanos Medical, Inc.Lack of sterility assurance for closed suction catheter systems
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical 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
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline 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.