ClearanceBrief
Panels › Cardiovascular › Product code OEZ · Class 2

Cardiovascular Procedure Kit

Regulation 870.1200

0510(k)s in 12 months (0 all time)
49recalls in 12 months (231 all time)
4recalls that name a 510(k)
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Top companies in OEZ

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline produc
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
Open, Classified
OEZNone listed
Sep 25, 2026American Contract Systems Inc
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH 0248495 Model No. RCOH62C
Open, Classified
OEZNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
Open, Classified
OEZNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number:
Open, Classified
OEZNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Open, Classified
OEZNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS98334
Open, Classified
OEZNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Open, Classified
OEZNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Open, Classified
OEZNone listed
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Open, Classified
OEZNone listed
Jul 30, 2026Medical Action Industries, Inc. 306
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Open, Classified
OEZNone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Open, Classified
OEZNone listed
Jul 10, 2026Argon Medical Devices, Inc
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Open, Classified
OEZNone listed
Jul 8, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
Open, Classified
OEZNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
Open, Classified
OEZNone listed
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ90
Open, Classified
OEZNone listed
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEA
Open, Classified
OEZNone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULA
Open, Classified
OEZNone listed
Jun 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS9822
Open, Classified
OEZNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
Open, Classified
OEZNone listed
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK
Open, Classified
OEZNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP
Open, Classified
OEZNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DY
Open, Classified
OEZNone listed
May 8, 2026Medline Industries, LP
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PA
Open, Classified
OEZNone listed
May 7, 2026Medline Industries, LP
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP C
Open, Classified
OEZNone listed
May 1, 2026AVID Medical, Inc.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Open, Classified
OEZNone listed
May 1, 2026AVID Medical, Inc.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Open, Classified
OEZNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS9848
Open, Classified
OEZNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783
Open, Classified
OEZNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673;
Open, Classified
OEZNone listed
Apr 7, 2026Medline Industries, LP
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline S
Open, Classified
OEZNone listed
Apr 1, 2026Medline Industries, LP
THORACIC ROBOTS, DYNJ908777B
Open, Classified
OEZNone listed
Mar 12, 2026Medline Industries, LP
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number:
Open, Classified
OEZNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Num
Open, Classified
OEZNone listed
Feb 9, 2026Medline Industries, LP
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Open, Classified
OEZNone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4)
Open, Classified
OEZNone listed
Jan 16, 2026Merit Medical Systems, Inc.
Merit Medical , Custom Manifold Kit REF: K09-13203A
Open, Classified
OEZNone listed
Jan 14, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Open, Classified
OEZNone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN
Open, Classified
OEZNone listed
Dec 5, 2025Medline Industries, LP
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Open, Classified
OEZNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF C
Open, Classified
OEZNone listed
Nov 13, 2025Medline Industries, LP
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Open, Classified
OEZNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209
Open, Classified
OEZNone listed

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