Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices posing a risk of patient harm through inaccurate dosing and device leakage. No illnesses or injuries have been reported. Per the severity rubric, recalls of high-risk products where injury has not yet been reported receive a 'High' (3) rating.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Presource Cardiac Catheterization Kit models because they contain Jiangsu Shenli Medical Production Co. Ltd syringes that are supplied as components within Merit Medical kit components. A total of 2,524 units have been distributed nationwide across the affected kit catalog numbers.
The Shenli syringes contained in these kits may have a significant design change or modification that could significantly alter the safety or effectiveness of the finished cardiac catheterization kit. This design defect creates a risk of patient harm, specifically the risk of inaccurate dosing and device leakage. The FDA has advised that these syringes cannot be distributed for use.
Healthcare facilities that have received these Presource Cardiac Catheterization Kits should immediately stop using the affected products and contact Cardinal Health for instructions on product disposition. Patients who may have received treatment using these kits should consult their healthcare provider if they have concerns about the procedure or experience any unexpected symptoms.
The recalled product
- Product
- Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 2,524
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) SAN69CCKRB
- UDI/DI (CS/EA) 50195594062079/10195594062071
- Lot Numbers: 205373
- 2) SAN73CCV10
- UDI/DI (CS/EA) 50195594753557/10195594753559
- Lot Numbers: 870093
- 3) SAN73CCV11
- UDI/DI (CS/EA) 50195594870773/10195594870775
- Lot Numbers: 915202
- 4) SAN73CCV12
- UDI/DI (CS/EA) 50197106021987/10197106021989
- Lot Numbers: 934300
- 5) SAN73CCV13
- UDI/DI (CS/EA) 50197106371433/10197106371435
- Lot Numbers: 86630
- 6) SAN73CCV14
- UDI/DI (CS/EA) 50197106559763/10197106559765
- Lot Numbers: 209283
- 8) SAN73CCVD8
- UDI/DI (CS/EA) 50195594589613/10195594589615
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · inaccurate dosing
See all →- HighPresource surgical kits recalled for syringe design defect risk
FDA (Devices) · 2024-07-17
- HighPresource Neurological Surgical Kits Recalled for Syringe Design Defect
FDA (Devices) · 2024-07-17
- HighMedline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- HighB Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues
FDA (Devices) · 2020-12-30
- HighB Braun APEX Compounding System Control Panel Module Recalled
FDA (Devices) · 2020-12-30
Similar recalls
- HighCardinal Health Laryngoscopy Presource Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-02-19
- HighCardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-02-19
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
- HighCardinal Health surgical kits recalled for potential endotoxin contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2025-02-19