Cardiac Catheterization Kit
FDA product code OES · Class II (moderate risk) · 21 CFR 870.1200 · 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
93recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3154-2026 | Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… | AVID Medical, Inc. | 08/10/2026Open, Classified |
| Z-3019-2026 Class II | Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2816-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX…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-2612-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | Medline Industries, LP | 05/28/2026Open, Classified |
| Z-2606-2026 Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… | Medline Industries, LP | 05/28/2026Open, Classified |
| Z-2536-2026 Class II | Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number:…The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A… | Medline Industries, LP | 05/21/2026Open, Classified |
| Z-2772-2026 Class II | Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing… | AVID Medical, Inc. | 05/19/2026Open, Classified |
| Z-2486-2026 Class II | MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU…During an internal review, Medline identified representative samples did not meet applicable performance… | Medline Industries, LP | 05/04/2026Open, Classified |
| Z-2797-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2796-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2443-2026 Class II | Medline convenience kits: PORT A CATH DYNJ906818AKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2417-2026 Class II | MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276GKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… | Medline Industries, LP | 04/27/2026Open, Classified |
| Z-2366-2026 Class I | Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2144-2026 Class I | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2015-2026 Class II | Medline 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, LP | 03/19/2026Open, Classified |
| Z-1979-2026 Class I | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1978-2026 Class I | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1973-2026 Class I | Halyard CATH LAB kit. Model Number: SACL75AM.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1972-2026 Class I | Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1971-2026 Class I | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1970-2026 Class I | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-2592-2026 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-2582-2026 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-1877-2026 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-1717-2026 Class I | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1835-2026 Class II | Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number:…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-2092-2026 Class II | Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1389-2026 Class II | Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1327-2026 Class II | Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU…Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD… | Medline Industries, LP | 12/24/2025Open, Classified |
| Z-1187-2026 Class II | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF…Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to… | Medline Industries, LP | 12/12/2025Open, Classified |
| Z-0512-2026 Class II | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | Medline Industries, LP | 09/30/2025Open, Classified |
| Z-0175-2026 Class II | Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | American Contract Systems Inc. | 09/04/2025Open, Classified |
| Z-1591-2025 Class II | Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE 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-1437-2025 Class II | Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number…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-1426-2025 Class II | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278…Sterility assurance with procedure trays | American Contract Systems, Inc. | 01/31/2025Open, Classified |
| Z-0777-2025 Class II | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… | MEDLINE INDUSTRIES, LP - Northfield | 11/21/2024Open, Classified |
| Z-0717-2025 Class II | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | MEDLINE INDUSTRIES, LP - Northfield | 11/06/2024Open, Classified |
| Z-0624-2025 Class II | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… | MEDLINE INDUSTRIES, LP - Northfield | 10/09/2024Open, Classified |
| Z-0455-2025 Class II | Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0448-2025 Class II | Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0447-2025 Class II | Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0441-2025 Class II | Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0438-2025 Class II | Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0437-2025 Class II | Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0431-2025 Class II | Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0430-2025 Class II | Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0427-2025 Class II | Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0422-2025 Class II | Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0418-2025 Class II | Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |
| Z-0412-2025 Class II | Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the… | AVID Medical, Inc. | 09/20/2024Open, Classified |