Anesthesia Kit
FDA product code OFQ · Class II (moderate risk) · 21 CFR 868.5120 · 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
8recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2943-2026 Class II | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number:…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-0443-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-3055-2024 Class II | Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2623-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-0816-2024 Class II | Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | American Contract Systems, Inc. | 11/29/2023Open, Classified |
| Z-0083-2024 Class II | Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center…Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | Cardinal Health 200, LLC | 08/16/2023Open, Classified |
| Z-1062-2023 Class II | LOCAL PACK. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-0863-2022 Class II | Lum Lam Custom Pack - Anesthesia KitThe outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Stradis Medical, LLC dba Stradis Healthcare | 02/25/2022Open, Classified |