Tracheobronchial Suction Catheter Kit

FDA product code OFR · Class I (low risk) · 21 CFR 868.6810 · Anesthesiology

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
7recalls

Recalls

RecallProductFirmInitiated
Z-2999-2026 Class IIMedline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330Component labeling discrepancy Medline Industries, LP07/10/2026Open, Classified
Z-2010-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-1706-2026 Class IIMedline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2.…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… Medline Industries, LP02/16/2026Open, Classified
Z-1312-2026 Class IIMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kitA smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of… Medline Industries, LP12/24/2025Open, Classified
Z-0629-2025 Class IIMEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-2985-2024 Class IIMedline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-1092-2024 Class IMEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified