FDA Device recall Z-0770-2019
Perfusion Pack, Rx only, Sterile EO
- FDA Device
- Class II
- terminated
- Published 2019-01-30
On 2019-01-30 the FDA classified a Class II recall of Perfusion Pack, Rx only, Sterile EO by Livanova Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0770-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-09 |
| Published | 2019-01-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV |
Product
Perfusion Pack, Rx only, Sterile EO
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.
Identifiers
| code_info | Lot Numbers: 1819000027, 1813500044, 1809300053, 1817900004, 1821900089, 1812100018, 1816200009, 1817600016, 1…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.