Cardiovascular Procedure Kits Recalled for Potential Syringe Design Defects
Cardinal Health recalls 17,445 cardiovascular procedure kits nationwide containing potentially defective syringes that could cause inaccurate dosing or device leakage.
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: FDA Class II medical device recall with theoretical risk of patient harm through inaccurate dosing and device leakage, but no reported illnesses or injuries. Fits rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource cardiovascular procedure kits and Left Heart Kits (17,445 units distributed nationwide) that contain syringes supplied by Merit Medical. The affected kits include 10 catalog numbers for Cardiovascular Procedure Kits and Left Heart Kits, with specific lot numbers detailed in the FDA recall notice.
The syringes in these kits are manufactured by Jiangsu Shenli Medical Production Co. Ltd. According to FDA communications, these syringes may contain a significant design modification that could alter the safety or effectiveness of the finished kit product. This design defect could result in inaccurate dosing or device leakage during cardiovascular procedures, creating a risk of patient harm.
Healthcare facilities and cardiovascular procedure centers that received these kits should cease use immediately and contact Cardinal Health or refer to FDA recall number Z-2329-2024 for complete lot number and catalog number information. Affected inventory should be segregated and handled according to FDA recommendations for product disposition.
The recalled product
- Product
- Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 17,445
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) SAN29ANCC3
- UDI/DI (CS/EA) 50888439692868/10888439692860
- Lot Numbers: 377162
- 2) SAN29ANCC4
- UDI/DI (CS/EA) 50888439791929/10888439791921
- Lot Numbers: 404590
- 3) SAN29ANCCL
- UDI/DI (CS/EA) 50887488572077/10887488572079
- Lot Numbers: 227924
- 248336
- 268411
- 295823
- 330354
- 441771
- 470382
- 485647
- 4) SAN29ANCCM
- UDI/DI (CS/EA) 50888439916933/10888439916935
- Lot Numbers: 538664
- 5) SAN33CDCAS
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.
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