Medi-Vac — Class II medical device recall Z-1546-2018
Terminated recall by Cardinal Health 200, LLC, reported 2018-05-09. products may be missing a one-way valve on the fluid patient port.
| Recall number | Z-1546-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2018-03-28 |
| Classified | 2018-04-30 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-11-29 |
| Quantity | 3,600 units |
| Lot numbers | J802-384, J802-386, J802-391, J802-396 |
| Model numbers | 6561-910C, 6561-916K, 6561-920C |
Product
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
Reason for recall
products may be missing a one-way valve on the fluid patient port.
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-1546-2018. 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.