Z-1203-2026Class II

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal...

Name: Z-1203-2026 Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal...
Creator: Cardinal Health 200, LLC
Published: 2025-12-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-12-26 / Open, Classified / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU... on 2025-12-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1203-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-26
Posted: 2026-01-28
Recalling firm: Medtronic, Inc.
Product: 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. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 1,169,726 units
Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
Product codes and lots: All units affected by IFU update. UDI-DI: 1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1203-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1203-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28

Product code GCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)