FDA-Device2026-03-18Class IIMISBRANDING
Medline cardiac drainage kits with Cardinal Health Aqua-Seal units recalled for age restriction clarification
LABEL MIX UPNationwide distribution
Check lot numbers on Medline cardiac drainage kits
Medline and Cardinal Health have recalled specific lots of chest drainage kits used in cardiac surgery because the instructions needed to clarify that these devices are intended only for adult patients age 18 and older. The kits were distributed nationwide in California and internationally to Chile and Panama.
- Check if your facility has any of the affected Medline cardiac drainage kits by matching the model numbers (DYNJ902487A, DYNJ908126, or DYNJ910851) and lot numbers listed in this recall
- Review updated instructions to confirm the adult-only age requirement
- Contact your Medline or Cardinal Health representative if you have questions about affected inventory
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.
Affected count
2894 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2026More Medline Industries, LP recalls
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