Angiography/Angioplasty Kit
FDA product code OEQ · Class II (moderate risk) · 21 CFR 870.1650 · 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
89recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2815-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2485-2026 Class II | MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2004-2026 Class II | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire | Merit Medical Systems, Inc. | 04/02/2026Open, Classified |
| Z-2003-2026 Class II | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire | Merit Medical Systems, Inc. | 04/02/2026Open, Classified |
| Z-2002-2026 Class II | Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire | Merit Medical Systems, Inc. | 04/02/2026Open, Classified |
| Z-2143-2026 Class I | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2014-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | Medline Industries, LP | 03/19/2026Open, Classified |
| Z-2591-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-2581-2026 Class II | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.…Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1876-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…Unapproved design changes to the products outside of the 510(k) clearance. | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1716-2026 Class I | Medline 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, LP | 02/27/2026Open, Classified |
| Z-1834-2026 Class II | Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2091-2026 Class II | Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1388-2026 Class II | Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1129-2026 Class II | Allwell Angioplasty Pack REF: IS-30-B1/BInflation device handle may detach from the syringe during procedure. | Merit Medical Systems, Inc. | 12/04/2025Open, Classified |
| Z-1128-2026 Class II | Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922BInflation device handle may detach from the syringe during procedure. | Merit Medical Systems, Inc. | 12/04/2025Open, Classified |
| Z-1124-2026 Class II | Allwell Inflation Device, for angiographic use REF: IS-30-AInflation device handle may detach from the syringe during procedure. | Merit Medical Systems, Inc. | 12/04/2025Open, Classified |
| Z-0180-2026 Class II | Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-1590-2025 Class II | Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-1430-2025 Class II | namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical…The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near… | MEDLINE INDUSTRIES, LP - Northfield | 02/12/2025Open, Classified |
| Z-1436-2025 Class II | Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 02/11/2025Open, Classified |
| Z-1340-2025 Class II | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | American Contract Systems Inc | 02/06/2025Open, Classified |
| Z-0154-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-0070-2025 Class II | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-3191-2024 Class II | Custom Procedure Kit, REF: K12T-110777F sheath introducers labeled as 7.5F | Merit Medical Systems, Inc. | 08/12/2024Open, Classified |
| Z-3235-2024 Class II | IR Procedure Pack, CEAT19W; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | American Contract Systems, Inc. | 08/07/2024Open, Classified |
| Z-3159-2024 Class II | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical… | ROi CPS LLC | 07/24/2024Open, Classified |
| Z-2579-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2573-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2568-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2567-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2562-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2560-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2558-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | Merit Medical Systems, Inc. | 06/11/2024Open, Classified |
| Z-2327-2024 Class II | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2)…Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli… | Cardinal Health 200, LLC | 05/29/2024Open, Classified |
| Z-2520-2024 Class II | American Contract Systems Special Procedure Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | American Contract Systems, Inc. | 05/06/2024Open, Classified |
| Z-2627-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2090-2023 Class II | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | DeRoyal Industries Inc | 05/30/2023Open, Classified |
| Z-2159-2023 Class II | Medline 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 - Northfield | 05/18/2023Open, Classified |
| Z-2296-2023 Class II | Custom 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 - Northfield | 05/15/2023Open, Classified |
| Z-1110-2023 Class II | Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-1065-2023 Class II | FEMORAL ARTERY PACK-LF. Sterile Procedural TraySterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-0554-2023 Class II | STRADIS HEALTHCARE, Angio Pack, Item No.686-199,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |
| Z-0553-2023 Class II | STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |
| Z-0544-2023 Class II | STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |
| Z-0525-2023 Class II | HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |
| Z-1689-2022 Class II | Various Angiography packs/traysProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | American Contract Systems, Inc. | 06/16/2022Open, Classified |
| Z-1256-2021 Class II | JUDKINS PACKComponent Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being… | Cardinal Health 200, LLC | 02/11/2021Terminated |
| Z-0751-2021 Class II | Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx…Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a… | Merit Medical Systems, Inc. | 11/10/2020Terminated |
| Z-0750-2021 Class II | Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO…Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a… | Merit Medical Systems, Inc. | 11/10/2020Terminated |