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DUBLIN, Ohio, March 28, 2024 -- In close collaboration with the U.S. Food and Drug Administration (FDA), Cardinal Health (NYSE: CAH) today issued a lot-specific voluntary removal of Jackson-Pratt™ 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. This product recall is lot-specific and other Jackson-Pratt™ 3-Spring Reservoir products are not impacted. (See table below for specific catalog and lot numbers impacted.)

While Cardinal Health has not received any complaints on this issue, the use of unsterilized Jackson-Pratt™ 3-Spring Reservoir kits can pose a risk of a post-operative wound infection or surgical site infection. We have initiated corrective and preventative actions to resolve this event and ensure future product requiring sterilization is routed and released appropriately.

Customers who received the listed lots were asked to return the affected product and follow the instructions below:

• REVIEW inventory for the affected product codes and lots. Location of product code and lot are shown in labels below.
• COMMUNICATE with all personnel that utilize the Jackson-Pratt™ 3-Spring Reservoir kits.
• SEGREGATE and quarantine all affected product upon review of inventory. Product should not be used and cease using the product immediately. Utilize return directions below to return product. 
• DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected products.
• DISTRIBUTORS should notify any customers who may have received affected product about this medical device product recall and share a copy of this notice.
• RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email directly to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not.

Our goal, always, is to provide safe, high-quality products, and we apologize for any frustration this issue has caused.

For additional questions related to this recall, please reach out to: fieldcorrectiveaction@cardinalhealth.com or call 800-292-9332.

IMPACTED PRODUCT