Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number… Recall
Issued July 17, 2024 · Cardinal Health 200, LLC
In July 2024, Cardinal Health 200, LLC recalled the Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cardinal Health 200, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Cardinal Health 200, LLC
- Category
- Health
- Recall date
- July 17, 2024
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-Z-2329-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Cardinal Health 200, LLC has 12 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.