REF CH3582 5 IN — Class II medical device recall Z-1566-2021
Ongoing recall by ICU Medical, Inc., reported 2021-05-19, distributed nationwide. Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers m
| Recall number | Z-1566-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-05-13 |
| Reported by FDA | 2021-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, ES, FR, GB, IT, ZA |
| Reason classes | packaging |
| Lot numbers | 5125197 |
| Model numbers | CH3582 |
Product
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Reason for recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
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-1566-2021. 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.