Cardiovascular Procedure Kit
Recall Summary Medline cardiovascular procedure kits containing Cardinal Health chest drainage units are being recalled because their instructions did not clearly specify that the devices are intended only for adult patients (18 years and older). The recall affects three kit models used in open heart and cardiac procedures, distributed nationwide in the US, plus Chile and Panama. This is a Class II recall, meaning the product could cause serious health problems or death.
- Product
- Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
- Reason
- The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/17a95f96-dccf-4604-a4b0-06952a3ab167