Burn Kit Without Drug
General, Plastic Surgery · 21 CFR 878.4022
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://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.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
7 recall events for this product code
- Medline Industries, LPOpen, ClassifiedMay 7, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2120-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 17, 2026
Medline Convenience Kits:
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1404-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedDec 5, 2024
MEDLINE convenience kits labeled as:
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Z-0637-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits, labeled as:
Medical 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 may pose a risk to patient health.
Z-3061-2024 · View FDA record ↗ - ROi CPS LLCOpen, ClassifiedOct 6, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Z-0070-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedFeb 6, 2023
Sterile Procedural Trays, labeled as the following:
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1083-2023 · View FDA record ↗ - Certified Safety Mfg IncTerminatedUnknown
Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank.
Burn Sheet has possibility of being shredded.
Z-3078-2017 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
North American Rescue, Llc.
Greer, SC, US
Sterigenics U.s., Llc
Charlotte, NC, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Deroyal Industries, Inc.
POWELL, TN, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Cardinal Health 200, Llc
El Paso, TX, US
Guatemala Medical Manufacturing
Villa Canales Guatemala, GT
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Medline Industries, Lp - Northfield
Northfield, IL, US
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Isomedix Operations Inc
El Paso, TX, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Midwest Sterilization Corp.
JACKSON, MO, US
Ortho And Surgical Products Enterprises S.a.
Villa Canales Guatemala, GT
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Midwest Sterilization Corp.
LAREDO, TX, US
Guangzhou Nuoning Medical Supplies Co.,ltd
Guangzhou Guangdong, CN
Safe N Simple Llc
Clarkston, MI, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Sterigenics U.s., Llc
Ontario, CA, US
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.