Kit w/3 Ext Sets — Class II medical device recall Z-2721-2017
Terminated recall by ICU Medical, Inc., reported 2017-07-19, distributed in AZ, OH, TX, WA. The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
| Recall number | Z-2721-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2017-05-30 |
| Classified | 2017-07-11 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2024-09-20 |
| Distributed | AZ, OH, TX, WA |
| Countries outside the US | FR, IT |
| Quantity | 100 units |
| Reason classes | packaging |
| Lot numbers | 3320753 |
| Model numbers | 011-AM6123 |
Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Reason for recall
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
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-2721-2017. 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.