Catheter Care Tray

FDA product code OHR · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology

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.

0510(k) clearances
0PMA approvals
16recalls

Recalls

RecallProductFirmInitiated
Z-2494-2026 Class IIMEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2484-2026 Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2483-2026 Class IIMEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2482-2026 Class IIMEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2481-2026 Class IIMEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2480-2026 Class IIMEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-0518-2026 Class IIMEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… Medline Industries, LP09/30/2025Open, Classified
Z-0632-2025 Class IIMEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0162-2025 Class IIMedline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-3010-2024 Class IIMedline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-1104-2024 Class IMEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified
Z-2175-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-2315-2023 Class IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. MEDLINE INDUSTRIES, LP - Northfield05/15/2023Open, Classified
Z-2133-2011 Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile…Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible… Apogee Medical, Inc03/24/2011Terminated
Z-0215-2012 Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… Medical Device Technologies, Inc.12/22/2010Terminated
Z-0214-2012 Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… Medical Device Technologies, Inc.12/22/2010Terminated