Central Venous Catheter Dressing Change Kit
General Hospital · 21 CFR 880.5200
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
51 adverse event reports on file
- CENTRAL LINE DRESSING KITJun 10, 2026InjuryUnkMW5189225
- CENTRAL LINE DRESSINGApr 13, 2026MalfunctionMedical Action Industries1030451-2026-00009
- CENTRAL LINE DRESSING KITFeb 23, 2026MalfunctionMedline Industries, Lp - SptMW5184228
- MEDICAL ACTION INDUSTRIESJan 7, 2026MalfunctionMedical Action Industries, Inc. 30623988430
- CENTRAL LINE CATHETER KITJan 6, 2026MalfunctionUnkMW5181818
- CENTRAL LINE CATHETER KITJan 6, 2026MalfunctionUnkMW5181819
- PORT ACCESS DRESSING CHANGE KITJul 15, 2025MalfunctionMedical Action IndustriesMW5172679
- CLEAR SEQUENCE CENTRAL LINE DRESSING CHANGEJul 11, 2025InjuryMedical Action Industries1030451-2025-00007
- KIT: CENTRAL LINE DRES 20/CSJan 8, 2025MalfunctionMedical Action Industries Inc.21101783
- MEDICAL ACTION INDUSTRIESSep 15, 2023MalfunctionMedical Action Industries Inc.17755291
Event type breakdown
Recalls
4 recall events for this product code
- Medical Action Industries, Inc. 306TerminatedMay 12, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Z-1554-2021 · View FDA record ↗ - Medical Action Industries, Inc. 306TerminatedMay 12, 2021
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Z-1557-2021 · View FDA record ↗ - Medical Action Industries, Inc. 306TerminatedUnknown
Kit: Central Line Dres Change 20/Cs
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Z-0147-2022 · View FDA record ↗ - Resource Optimization & Innovation LLCTerminatedUnknown
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascula
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Z-2369-2020 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Solventum Us Llc
Eagan, MN, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Sterigenics Us Llc
Grand Prairie, TX, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Isomedix Operations Inc
El Paso, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
Su Biyomedikal Sistemler Ve Saglik Hiz. San. Ve Tic. A. S.
Tekirdag, TR
Resource Optimization & Innovation, Llc
Nashville, TN, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Isomedix Operations, Inc.
Minneapolis, MN, US
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Solventum Us Llc
San Antonio, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Cardinal Health 200, Llc
El Paso, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Midwest Sterilization Corp.
LAREDO, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Medline Industries, Lp - Spt
Waukegan, IL, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.