In response to ongoing FDA communications regarding plastic syringes manufactured in China, Cardinal Health has initiated a product recall of plastic syringes produced by Jiangsu Shenli Medical Production Co. Ltd (Shenli). These syringes are included in Merit Medical (Merit) finished kits, which are components of Cardinal Health Presource kits. The FDA has indicated that these Shenli syringes lack FDA clearance.
Consequently, on May 28, 2024, Cardinal Health issued a voluntary product recall affecting Presource kits containing Merit finished kits with Shenli syringes. Customers who received the affected lots are instructed to:
- QUARANTINE the affected kits and NOTIFY their clinicians of this action.
- PLACE a WARNING LABEL on the front of each Presource kit, making it clearly visible to clinicians. The label should instruct them to remove and discard all syringes within the affected Merit kit in the Presource product.
- RETURN a copy of the enclosed Acknowledgment Form, confirming receipt of this action and completion of the labeling process, via fax to 614.652.9648.
After the Shenli syringes are removed and discarded according to these instructions, the remaining components of the Merit kit are considered safe for use.
Merit Medical has also recently issued a voluntary recall related to Shenli syringes. Following this, Cardinal Health evaluated the impact on Presource kits and expanded the list of affected products. (Please download the complete list here.)
Our priority is to provide safe, high-quality products, and we apologize for any inconvenience this issue may have caused.
