DISTALE — Class II medical device recall Z-0271-2021
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-0271-2021 |
|---|---|
| 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 | 10840619093201 |
| Lot numbers | 4537216, 4726595 |
Product
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap. 1 unit per pouch, 20 pouches per case. UDI:(01)10840619093201(17)241201(30)20(10)4537216, (01)10840619093201(17)250201(30)20(10)4726595. . Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
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-0271-2021. 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.