Device Recall COBE Blood oxygenator

Catalog # 050255500, Lot Numbers 0608000009, 0610800078, 0613600057...Catalog # 050316400, Lot Numbers 0607300017, 0608000011, 0608700110, 0608800063, 0609400137, 0610100174, 0610200062, 0610800080, 0611600081, 0612200144, 0612900020, 0612900039, 0613600059....Catalog # 050412400, Lot Number 0608000010, 0608700109, 0609400136, 0610800079, 0611600080, 0612200143, 0612900038, 0613000001.... Catalog # 050500000, Lot Number 0609400138, 0610100176, 0611600082, 0612200146.

Cardiovascular Devices

2

No

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc..

Catalog # 050226400, Lot Numbers: 0607300026, 0609400146, 0610100183, 0611600089, 0612200155, 0612900044. ...Catalog # 050422400, Lot Numbers: 0607300025, 0608000018, 0608700122, 0610800088.

Cardiovascular Devices

2

No

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc..

Catalog # 050125400, Lot Numbers: 0610800081, 0613600060, 0614400061....Catalog # 050502000, Lot number 0612200145.

Cardiovascular Devices

2

No

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc..

Serial numbers: 0609400012, 0609400029, 0611500069, 0611500082, 0612800162, 0614300012, 0614300033, 0610800032, 0612800057, 0613600155, 0611500073, 0614300014, 0612200082, 0612200097, 0613600017, 0611500011, 0612800111, 0611500037, 0613500120, 0615000130, 0610100013, 0610100022, 0610100023, 0611500012, 0611500022, 0611500023, 0611500024, 0611500074, 0613600044, 0611600153, 0614200056, 0610100063, 0612800086, 0615000047, 0615000057, 0612200035, 0610100082, 0611500014, 0613500121, 0614300045, 0612200011, 0613500075, 0613500076, 0615000049, 0611500099, 0613500097, 0613500104, 0614300067, 0612800142, 0612200058, 0615200006, 0612400011, 0611500038, 0612200012, 0614200088, 0612200059, 0614300017, 0611500015, 0615000099, 0612200036, 0610800019, 0615000133, 0612800143, 0615000051, 0612200061, 0615000100, 0613600046, 0614300068, 0612200038, 0613800007, 0614300001, 0610100084, 0614300018, 0612200014, 0612200126, 0612800089, 0615000073, 0612800168, 0610900041, 0613100004, 0610900044, 0612800090, 0613600021, 0610800116, 0612200084, 0615000074, 0612200016, 0612800144, 0611500100, 0612800145, 0611500039, 0612800068, 0612400007, 0614200090, 0609400054, 0610100042, 0611500040, 0613600022, 0610800048, 0610800117, 0612200086, 0613600023, 0609400055, 0611500041, 0612800091, 0615000052, 0609400129, 0610100103, 0610700029, 0608900036, 0608900037, 0615200007, 0612900006, 0610100104, 0613800003, 0614300046, 0609400057, 0609400167, 0611500076, 0609400058, 0613600025, 0615000075, 0612200017, 0610100085, 0610100043, 0611600119, 0610100087, 0614300021, 0609400093, 0612200064, 0610800118, 0614300022, 0609400059, 0611500118, 0610100067, 0610100071, 0613100005, 0613100006, 0608700021, 0610100088, 0612800115, 0612200042, 0612200049, 0612200019, 0614300072.

Cardiovascular Devices

2

No

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006. COBE Cardiovascular, Inc..

Serial numbers: 0614200085, 0610800149, 0612800146, 0614200089, 0610800022, 0612800069, 0614300069, 0609400089, 0609400102, 0609400103, 0610800049, 0612800114, 0612800125, 0612800126, 0609400091, 0614200058, 0614200069, 0610800151, 0614300071, 0609400130, 0611500101, 0614200059, 0613500077, 0613500083, 0612200040, 0614200060, 0612200063, 0614300020, 0612800074, 0610100066, 0612200065.

Cardiovascular Devices

2

No

Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 078428010, 078688007, 078869003. COBE Cardiovascular, Inc..