Cardinal Health recalls specific Presource kits and trays due to potential inaccurate dosing and leaking device risks from Shenli syringes. Affected kits include Cardiovascular Procedure Kits with catalog numbers SAN29ANCC3 through SAN73LHKC6.
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 specific Presource kits and trays that contain syringes from a manufacturer with potential design changes. These changes could lead to inaccurate dosing or a leaking device, risking patient harm during medical procedures.
The syringes in the affected kits were produced by Jiangsu Shenli Medical Production Co. Ltd, which may have made design changes that alter the safety or effectiveness of the kits. This could result in inaccurate dosing or the device leaking during medical procedures, potentially harming patients.
Healthcare providers using the recalled Presource kits and trays for cardiovascular procedures are most at risk. Patients receiving treatments with these kits could face inaccurate dosing or device leaks.
Check for Presource kits labeled as Cardiovascular Procedure Kits with catalog numbers SAN29ANCC3 through SAN73LHKC6. Look for specific lot numbers listed in the recall notice for each catalog number.
Identify the catalog number on your Presource kit (e.g., SAN29ANCC3) to determine if it is affected.
Reach out to Cardinal Health 200, LLC for assistance with the recall process.
The recall is due to potential design changes in syringes from Jiangsu Shenli Medical Production Co. Ltd that could alter the safety or effectiveness of the Presource kits, risking inaccurate dosing or leaks.
Presource kits labeled as Cardiovascular Procedure Kits with catalog numbers SAN29ANCC3 through SAN73LHKC6 are affected, including specific lot numbers listed in the recall notice.
Check the catalog number and lot numbers on your kit. Contact Cardinal Health 200, LLC for further instructions on the recall process.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-2329-2024 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-2329-2024 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.
