30 cm — Class II medical device recall Z-2799-2018
Terminated recall by ICU Medical de Mexico, S.A. de C.V., reported 2018-08-22, distributed in AZ, MA, NC, OH, TX, VA, WA. ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administrat
| Recall number | Z-2799-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical de Mexico, S.A. de C.V., Ejido Maneadero, Mexico |
| Recall initiated | 2018-03-01 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2024-01-26 |
| Distributed | AZ, MA, NC, OH, TX, VA, WA |
| Countries outside the US | BE, DE, FR |
| Quantity | 100 pouches |
| Reason classes | packaging |
| Lot numbers | 3303902, 3380550 |
| Model numbers | 011-AM3003 |
| Expiration dates | 2021-08-01, 2021-12-01 |
Product
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Reason for recall
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
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-2799-2018. 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.