Suture Kit
FDA product code OVN · Class II (moderate risk) · 21 CFR 878.4830 · General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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
10recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1933-2026 Class II | LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently… | LSL Healthcare Inc. | 03/09/2026Open, Classified |
| Z-1194-2026 Class II | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… | Medline Industries, LP | 12/12/2025Open, Classified |
| Z-3026-2024 Class II | Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130AMedical 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-1957-2014 Class II | Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1956-2014 Class II | McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1955-2014 Class II | Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1954-2014 Class II | Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1953-2014 Class II | Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1952-2014 Class II | Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |
| Z-1950-2014 Class II | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Medical Action Industries Inc | 06/12/2014Terminated |