Perfusion Pack — Class II medical device recall Z-0770-2019
Terminated recall by LivaNova USA, reported 2019-01-30, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surg
| Recall number | Z-0770-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Arvada, CO, United States |
| Recall initiated | 2018-11-09 |
| Classified | 2019-01-23 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2022-05-03 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 483 |
| Reason classes | packaging |
| Lot numbers | 1803600019, 1803600044, 1803600047, 1803700065, 1803700066, 1803700072, 1803700075, 1803800017, 1803900021, 1804500029, 1804600025, 1805100104, 1805200031, 1805200035, 1805200043, 1805200067, 1805300025, 1805800065, 1805900033, 1805900035, 1805900040, 1806000020, 1806000024, 1806000029, 1806100020, 1806100041, 1806400043, 1806400048, 1806400055, 1806600023, 1806600028, 1806600030, 1806600059, 1806600064, 1806700039, 1807100016, 1807100026, 1807100034, 1807100035, 1807100040 and 443 more |
Product
Perfusion Pack, Rx only, Sterile EO
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0770-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.