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RespVac™

CUTTING EDGE HC BRANDS LLC · Model RTG-02206 · UDI-DI 00850108006288

BSY Prescription
10
510(k) clearances
3,457
Adverse events (42 deaths)
89
Recalls
248
Facilities

Description

RespVac Suction Catheter Kit Sterile 6FR

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.