LivaNova USA recalls Perfusion Pack, Rx only, Sterile EO

Hazard / Issue

4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.

Issued by

FDA

Affected States: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS

Lot/Code Info: Lot Numbers: 1819000027, 1813500044, 1809300053, 1817900004, 1821900089, 1812100018, 1816200009, 1817600016, 1810600004, 1811400014, 1812000017, 1812700017, 1813500013, 1815500011, 1816400023, 1809400005, 1811600025, 1812000018, 1812700018, 1813500014, 1814100012, 1815800010, 1810600006, 1811300003, 1812000019, 1812700020, 1815500012, 1817600017, 1813400007, 1814200096, 1816200011, 1817100013, 1813600009, 1817100103, 1819100014, 1810600014, 1812000030, 1815600027, 1817200017, 1819100017, 1810600015, 1816300051, 1815800015, 1817800028, 1810100021, 1810800022, 1811500019, 1812200022, 1813500020, 1814400026, 1815800017, 1816500016, 1817900015, 1810000025, 1810800023, 1811400022, 1812200023, 1813400010, 1814100019, 1816300053, 1810100022, 1812000034, 1812700032, 1814400027, 1816400032, 1817800031, 1819200020, 1812700034, 1814900020, 1817600031, 1814300026, 1818400082, 1819700023, 1820400020, 1814100022, 1816400035, 1818600024, 1811000017, 1815100030, 1816400036, 1819000012, 1809500011, 1810700016, 1812000036, 1814100023, 1815800018, 1810200011, 1814900021, 1817900017, 1806000020, 1807200053, 1810700018, 1811300015, 1812700035, 1816400037, 1819000013, 1810000027, 1812800072, 1814900022, 1813700002, 1817700022, 1819200022, 1810100026, 1811400028, 1803900021, 1805300025, 1805900033, 1806600023, 1807100016, 1810700020, 1811500023, 1813700014, 1814400028, 1816200018, 1817200020, 1811600032, 1814900023, 1816500019, 1817900019, 1812800073, 1815800019, 1819000016, 1810600022, 1813600016, 1818300026, 1810200014, 1812200029, 1814200103, 1815600031, 1816400039, 1818400085, 1821100028, 1810600023, 1810900022, 1813000021, 1817900021, 1803600019, 1803800017, 1805900035, 1806100020, 1806700039, 1807400038, 1808600021, 1812900030, 1813000022, 1806600064, 1814400031, 1816500022, 1818300027, 1817200022, 1810800024, 1812300012, 1804500029, 1806000024, 1810600024, 1812300013, 1818300028, 1810800025, 1812300014, 1813600019, 1819100023, 1811400001, 1811300019, 1811600034, 1812200032, 1814400033, 1819000020, 1809400017, 1814900027, 1815600032, 1810600026, 1811600035, 1817700026, 1819200027, 1810100028, 1813400015, 1815800021, 1817600036, 1810200016, 1811400031, 1812700040, 1815500028, 1816200021, 1816500024, 1818600028, 1811500024, 1812900031, 1814400034, 1816900018, 1812900032, 1817100021, 1817800035, 1813000025, 1816300058, 1819200028, 1811400033, 1814200105, 1816900020, 1817900023, 1807800020, 1808100036, 1805200067, 1810100030, 1819200029, 1806000029, 1807400042, 1813400017, 1816200024, 1815000041, 1818600030, 1819100025, 1810800030, 1812300017, 1816200027, 1816400043, 1817000037, 1817600038, 1819300025, 1809300068, 1813600022, 1816400079, 1821100036, 1809500017, 1811500029, 1811600040, 1812200037, 1814300030, 1815100034, 1815800023, 1817000038, 1817700032, 1818600032, 1812100075, 1813400057, 1814200109, 1814300031, 1820600034, 1810600029, 1812900034, 1813500027, 1819000023, 1810800033, 1813000032, 1813700022, 1816500025, 1814400069, 1810600032, 1811500033, 1813400021, 1815100037, 1818400090, 1812900039, 1813500029, 1816500026, 1818600034, 1810800034, 1811300023, 1812000043, 1813700025, 1814900031, 1816200029, 1816500027, 1817000040, 1818300031, 1804600025, 1805800065, 1806600028, 1810100035, 1811600042, 1813500030, 1816200030, 1812200001, 1816400087, 1816400048, 1817600041, 1811000008, 1810800065, 1817100025, 1817600042, 1817900029, 1812000088, 1818600079, 1816400050, 1812900041, 1814100030, 1815800024, 1810100081, 1810700112, 1811300062, 1817600043, 1818300033, 1805200031, 1805900040, 1807200067, 1812100042, 1815000047, 1817100027, 1811500035, 1812800074, 1822100076, 1810900029, 1813000033, 1814200112, 1814900035, 1815600039, 1816400051, 1814100032, 1816900025, 1812200045, 1815600041, 1817000042, 1817900030, 1812000010, 1805200035, 1806600030, 1809500023, 1811400037, 1813600030, 1810000033, 1811600046, 1813000039, 1815100041, 1815800028, 1817100030, 1818400143, 1814900036, 1813600001, 1814100001, 1812300001, 1815100065, 1809500025, 1811400040, 1812200050, 1813500036, 1813700027, 1815800031, 1816500032, 1818600039, 1810600036, 1811500039, 1812900044, 1816200031, 1817000044, 1818400096, 1817700085, 1818600075, 1809900043, 1811600049, 1817700038, 1818600040, 1807100026, 1807800034, 1810000035, 1812300023, 1810700030, 1809900044, 1812200051, 1819000029, 1819200036, 1810600037, 1811500042, 1812200052, 1814900040, 1816200033, 1817800043, 1815800033, 1821200047, 1809500028, 1812000047, 1809900048, 1810800040, 1813500041, 1815500034, 1817700039, 1816500033, 1805100104, 1806400043, 1807400052, 1809500030, 1812100053, 1813500042, 1818400097, 1810200032, 1815600050, 1816500036, 1810800043, 1813400028, 1818300039, 1818400098, 1815600051, 1810800044, 1818300040, 1810200033, 1812300026, 1815100046, 1817800070, 1818600042, 1810100043, 1817200037, 1812000050, 1812300029, 1816300076, 1817700042, 1810100044, 1810700034, 1811400048, 1812300030, 1813700031, 1817200038, 1807100034, 1803700065, 1806400048, 1807100035, 1808500045, 1810800045, 1812000051, 1814300043, 1815700038, 1817700043, 1818600044, 1803700066, 1805200043, 1811400062, 1813400034, 1813700032, 1810700038, 1803600044, 1806100041, 1807100040, 1808800042, 1812300032, 1813600036, 1816200040, 1817900042, 1810800046, 1811500052, 1812800085, 1813600037, 1818600047, 1803700072, 1811600060, 1812700059, 1815800045, 1819100045, 1813600039, 1815800046, 1817800051, 1808600043, 1803600047, 1803700075, 1811000043, 1812700061, 1814400048, 1817800052, 1809500037, 1811000044, 1815500042, 1816400064, 1818600051, 1810000045, 1812000062, 1811300042, 1811600066, 1815500045, 1819000047, 1816400068, 1817100047, 1819100050, 1809500040, 1811600067, 1813500049, 1815000056, 1817800054, 1812000002, 1813700038, 1815800050, 1806400055, 1808500048, 1806600059, 1819000051, 1817800055, 1813400049, 1819000054