Body Fluid Clean Up Kit
General, Plastic Surgery · 21 CFR 878.4040
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 11, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Z-3116-2024 · 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-3039-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
Medline medical procedure kits labeled as follows:
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2710-2024 · View FDA record ↗
Registered firms
21 firms currently registered for this product code
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Medegen Medical Products
GALLAWAY, TN, US
Specialty Medical Products Co.
N Salt Lake, UT, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Cardinal Health 200, Llc
Waukegan, IL, US
Safeguard Us Operating, Llc
Huntersville, NC, US
Jet Distribution Services Inc
Teterboro, NJ, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Redicare Llc
Congers, NY, US
Isomedix Operations Inc
El Paso, TX, US
Lsl Healthcare
Niles, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
EL PASO, TX, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
El Paso, TX, US
Midwest Sterilization Corp.
LAREDO, TX, US
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.