Recall Z-1203-2026 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cardinal Health 200, LLC
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571
| Date | Jan 28, 2026 (initiated Dec 26, 2025) |
| Status | Open, Classified |
| Reason | The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization. |
| Root cause | Error in labeling |
| Action | On December 26, 2025, the firm notified customers via Urgent Medical Device Product Advisory letters. Customers were instructed to continuing utilizing the CDUs on adult patients (not pediatric patients or infants). The updated IFU for affected product codes can be found at https://www.mycardinalmsds.com/ |
| Quantity | 1,169,726 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.