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
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24FBS256; 24) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBP532; 25) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBA256; 26) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24ABN040; 27) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBP214; 28) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBJ077; 29) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23IBQ646; 30) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23HBU475; 31) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE710; 32) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE709; 33) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23FBF593; 34) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBJ852; 35) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBC954; 36) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 22KBO714; 37) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25IBK435; 38) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBT069; 39) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBO806; 40) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBH137; 41) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25GBA989; 42) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 24LBJ019
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.