Custom Anesthesia Tray
Anesthesiology · 21 CFR 868.5120
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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- 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-2986-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 3, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2294-2023 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedJul 20, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2157-2023 · View FDA record ↗ - Deroyal Industries, Inc. LafolletteTerminatedOct 6, 2011
Custom anesthesia kits labeled as follows:
The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.
Z-0015-2012 · View FDA record ↗ - Avid Medical, Inc.TerminatedUnknown
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Z-1518-2020 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Midwest Sterilization Corp.
LAREDO, TX, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
El Paso, TX, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Custom Interventional Pain Management
San Antonio, TX, US
Pajunk Medical Systems
Alpharetta, GA, US
Cardinal Health 200, Llc
Waukegan, IL, US
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics U.s., Llc
Atlanta, GA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.