Infusion Pump I — Class II medical device recall Z-0137-2020
Terminated recall by ICU Medical Inc, reported 2019-10-23, distributed nationwide. Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
| Recall number | Z-0137-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-07-29 |
| Classified | 2019-10-14 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2024-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CL, DE, ES, FR, GB, GR, HK, IE, IT, OM, PH, PL, SA, TR, TW, ZA |
| Quantity | 280,826 units |
| Reason classes | packaging |
| Lot numbers | 3845287, 3849199, 3864779, 855575H, 865265H, 876065H, 885425H, 896175H, 918685H, 925775H, 929095H, 936455H, 945745H |
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Reason for recall
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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-0137-2020. 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.