The Recall Desk

FDA (Devices) recall action 94763

Cardinal Health 200, LLC recalled 4 products on 2024-07-17

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2024-07-17
Critical
0
Units
170,209

Why these products were recalled

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-17

    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.

    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 SAN29ANCC
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-17

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-07-17

    Presource Neurological Surgical Kits Recalled for Syringe Design Defect

    Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.

    Product
    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
    Category
    Distribution
    0 states