30" — Class II medical device recall Z-0705-2021
Ongoing recall by ICU Medical, Inc., reported 2020-12-30, distributed nationwide. Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may pote
| Recall number | Z-0705-2021 |
|---|---|
| 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 | 2020-08-31 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, DE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, LU, MY, NL, PL, RO, SE, SG, SK, TH, TR, TW, ZA |
| Quantity | 325 |
| Reason classes | packaging |
| Lot numbers | 4727479, 4784305 |
| Model numbers | CH3286 |
Product
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Reason for recall
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
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-0705-2021. 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.