United StatesMedline is recalling Medline kits that contain Cardinal Health Aqua‑Seal Chest Drainage Units sold as OPEN HEART (model DYNJ902487A), CARDIAC PROCEDURE (model DYNJ908126) and CARDIO CONGENITO (model DYNJ910851); affected kits were distributed worldwide including US (nationwide and CA), Chile and Panama, totaling 2,894 units with specified UDI‑DI and lot numbers. The recall was initiated because the instructions for use were updated to clarify the devices are intended for adult patients 18 years and older.
What's being recalled
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
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
1) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22KMG297; 2) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22FMA481; 3) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21IMG797; 4) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMG569; 5) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMB801; 6) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 26ABL637; 7) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467M; 8) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467; 9) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBG183; 10) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25HBF488; 11) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25GBK350; 12) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25FBO822; 13) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBT976; 14) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP602; 15) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP589; 16) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP588; 17) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP587; 18) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP586; 19) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25DBB810; 20) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25ABA001; 21) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24HBM020; 22) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24GBC436; 23) DYNJ908126…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)