8 IN — Class II medical device recall Z-0262-2021
Terminated recall by ICU Medical, Inc., reported 2020-10-28, distributed nationwide. Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lo
| Recall number | Z-0262-2021 |
|---|---|
| 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 | 2020-07-06 |
| Classified | 2020-10-22 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2023-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, DE, FR, IE, JP, MX, PL, SA |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10887709085814 |
| Lot numbers | 4605676 |
Product
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. .
Reason for recall
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
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-0262-2021. 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.