Cardinal Health recalls specific Presource cardiac catheterization kits due to potential inaccurate dosing and leaking devices from syringes made by a Chinese manufacturer.
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 of patient harm such as inaccurate dosing and a leaking device.
Cardinal Health is recalling certain Presource cardiac catheterization kits that contain syringes from a Chinese manufacturer. These syringes may cause inaccurate dosing or leaking, which could harm patients during medical procedures.
The syringes in these kits were made by Jiangsu Shenli Medical Production Co. Ltd (Shenli) in China. These syringes may have design changes that cause inaccurate medication dosing or leaks during medical procedures, potentially harming patients.
Healthcare professionals using the recalled kits for cardiac catheterization procedures are most at risk. Patients undergoing these procedures with the affected kits could face inaccurate dosing or device leaks.
Check for kits labeled as Cardiac Catheterization with catalog numbers SAN69CCKRB through SAN73CCVDI. Look for specific lot numbers listed in the recall notice.
Look for the catalog numbers SAN69CCKRB to SAN73CCVDI on the kit labels and associated lot numbers.
Reach out to Cardinal Health 200, LLC for assistance with the recall process.
The syringes in these kits were made by Jiangsu Shenli Medical Production Co. Ltd (Shenli) in China and may have design changes that cause inaccurate dosing or leaks during medical procedures.
Presource kits labeled as Cardiac Catheterization with catalog numbers SAN69CCKRB through SAN73CCVDI, including specific lot numbers listed in the recall notice.
Check the catalog number on the kit label and compare it to the list of affected numbers (SAN69CCKRB to SAN73CCVDI) and associated lot numbers.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-2328-2024 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-2328-2024 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
