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.
What this means for you
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 SAN73CCV1
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- inaccurate-dosing
- device-leakage
- design-defect
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.
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