Central Venous Catheter Tray

FDA product code OFF · Class II (moderate risk) · 21 CFR 870.1140 · Cardiovascular

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
50recalls

Recalls

RecallProductFirmInitiated
Z-3123-2026 Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… Medline Industries, LP08/11/2026Open, Classified
Z-3050-2026 Class IIMedline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… Medline Industries, LP06/12/2026Open, Classified
Z-2608-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… Medline Industries, LP05/28/2026Open, Classified
Z-2454-2026 Class IMedline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2)…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… Medline Industries, LP05/06/2026Open, Classified
Z-2488-2026 Class IIMEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2445-2026 Class IIMedline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2419-2026 Class IIMedline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG…Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-2017-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-2594-2026 Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… Medline Industries, LP02/27/2026Open, Classified
Z-1891-2026 Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. Medline Industries, LP02/27/2026Open, Classified
Z-1719-2026 Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… Medline Industries, LP02/27/2026Open, Classified
Z-1837-2026 Class IIMedline Kits: 1) PICC TRAY, Model Number: DYNJ41648AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… Medline Industries, LP02/25/2026Open, Classified
Z-1708-2026 Class IIMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT…Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated… Medline Industries, LP02/16/2026Open, Classified
Z-2094-2026 Class IIMedline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1391-2026 Class IIMedline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1329-2026 Class IIMedline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU…Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD… Medline Industries, LP12/24/2025Open, Classified
Z-1051-2026 Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets…Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to… Medline Industries, LP11/26/2025Open, Classified
Z-0514-2026 Class IIMEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… Medline Industries, LP09/30/2025Open, Classified
Z-0177-2026 Class IIMedical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… American Contract Systems Inc.09/04/2025Open, Classified
Z-1593-2025 Class IIMedline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1439-2025 Class IIMedline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield02/11/2025Open, Classified
Z-0779-2025 Class IIMedline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… MEDLINE INDUSTRIES, LP - Northfield11/21/2024Open, Classified
Z-0626-2025 Class IIMEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0157-2025 Class IIMedline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-2997-2024 Class IIMedline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC…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-2745-2024 Class IIMedline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516…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-0819-2024 Class IICustom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… American Contract Systems, Inc.11/29/2023Open, Classified
Z-1097-2024 Class IMEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… MEDLINE INDUSTRIES, LP - Northfield11/15/2023Open, Classified
Z-0525-2024 Class IISTERILE PVP SOLUTION, REF DYNDA1907The product description on the labeling includes the word "Sterile" or STRL", however the contents of the… MEDLINE INDUSTRIES, LP - Northfield11/03/2023Open, Classified
Z-0312-2024 Class IICENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562This recall is being issued due to items within the kit have expired prior to the overall kit expiration… MEDLINE INDUSTRIES, LP - Northfield11/01/2023Open, Classified
Z-2168-2023 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-2167-2023 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-2306-2023 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-2305-2023 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-0941-2023 Class IIHCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care TechnologyPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… Stradis Healthcare12/15/2022Open, Classified
Z-0940-2023 Class IIHCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care TechnologyPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… Stradis Healthcare12/15/2022Open, Classified
Z-1113-2023 Class IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… MEDLINE INDUSTRIES, LP - Northfield12/07/2022Open, Classified
Z-1068-2023 Class IISterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified
Z-0265-2023 Class IIB. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac)…The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. Medical Action Industries, Inc. 30609/15/2022Terminated
Z-0088-2023 Class IIVENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure…Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET… MEDLINE INDUSTRIES, LP - Northfield09/01/2022Terminated
Z-1692-2022 Class IIVarious PICC Line, Central Line PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. American Contract Systems, Inc.06/16/2022Open, Classified
Z-1471-2022 Class IIMedline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes:…Kits contain leaking bottles of isopropyl alcohol Medline Industries, LP - SPT06/06/2022Open, Classified
Z-0361-2022 Class IIVenous Access Pack-LF Convenience KitNaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Medline Industries Inc10/27/2021Terminated
Z-1556-2021 Class IKit: Midline Insertion DA. MAI Kit Part Number: 77981BMedical convenience kits are being recalled due to a potential breach in the package integrity of a… Medical Action Industries, Inc. 30604/09/2021Terminated
Z-2368-2020 Class IIRegard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush…There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and… Resource Optimization & Innovation LLC05/04/2020Terminated
Z-1045-2020 Class IICenturion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC…Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated
Z-1044-2020 Class IICenturion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC…Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated
Z-2378-2018 Class IIBARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For…One of the cases of product might not have been sterilized. Medline Industries, Inc.01/12/2018Terminated
Z-2458-2015 Class IICentral Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit…The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect… Medline Industries Inc08/03/2015Terminated
Z-1572-2009 Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter)…The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due… Tri-State Hospital Supply Corporation04/08/2008Terminated