Device product
Perfusion Pack, Rx only, Sterile EO
Z-0770-2019
Product summary
- Firm
- LivaNova USA
- Event
- Event 81667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 483
- Official record key
device-enforcement:Z-0770-2019
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Worldwide Distribution - Domestic (US) Consignees: 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, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada
Derived failure modes
-
Unknown
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.