Perfusion Pack recall
Perfusion Pack, Rx only, Sterile EO
Why was Perfusion Pack recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Perfusion Pack, Rx only, Sterile EO
- Recalling firm
- LivaNova USA
- Quantity
- 483
- Distribution
- 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
- Recall date
- January 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)