Catheter Care Tray
Gastroenterology, Urology · 21 CFR 876.5130
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
944 adverse event reports on file
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08138
- Bardia® Foley Catheter Insertion TrayJul 27, 2026InjuryC.r. Bard Inc. (covington) -10182331018233-2026-04873
- Medline Pre-Connected Vinyl Intermittent Catheter TraysJul 27, 2026MalfunctionMedline Industries, Lp1417592-2026-07508
- MEDLINEJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07069
- MEDLINE 100% SILICONE 1-LAYER FOLEY CATHETER TRAYSJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05876
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05207
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05849
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05844
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05845
- MEDLINEJul 15, 2026MalfunctionMedline Industries, Lp1417592-2026-05847
Event type breakdown
Recalls
16 recall events for this product code
- Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes:
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2480-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2481-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2482-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2483-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2484-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedJun 17, 2026
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2494-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 14, 2025
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Z-0518-2026 · 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-0632-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedOct 23, 2024
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Z-0162-2025 · 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-3010-2024 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Convatec, Inc.
Greensboro, NC, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Sterigenics Us Llc
Grand Prairie, TX, US
Midwest Sterilization Corp.
LAREDO, TX, US
Medline Soluciones Medicas
Nuevo Laredo Tamaulipas, MX
Primecare Medical (suzhou) Co.,ltd.
Changshu Jiangsu, CN
Hr Pharmaceuticals, Inc D/b/a Hr Healthcare
York, PA, US
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Medline Industries, Lp - Laredo
LAREDO, TX, US
Lsl Healthcare
Niles, IL, US
Microtrol Sterilisation Services Pvt. Ltd.
Rewari Haryana, IN
Able Solutions. Inc
Harrisonburg, VA, US
Hangzhou Jimushi Meditech Co., Ltd.
Hangzhou Zhejiang, CN
Hollister Incorporated
LIBERTYVILLE, IL, US
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.
SUZHOU Jiangsu, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Conod Medical Co., Ltd.
Hangzhou Zhejiang, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Hollister, Inc.
Mount Juliet, TN, US
Medline Industries, Lp - Spt
Waukegan, IL, US
Isomedix Operations Inc
El Paso, TX, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.