NORMOFLO Irrigation Warming administration set — Class I medical device recall Z-2377-2021
Ongoing recall by Smiths Medical ASD Inc., reported 2021-09-15, distributed nationwide. There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions
| Recall number | Z-2377-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-09-03 |
| Reported by FDA | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, ES, FI, FR, GB, GR, HK, HU, IE, IT, KW, LU, NL, NZ, PA, PL, PT, SE, TR, VE, ZA |
| Quantity | 519,250 |
| Model numbers | IR-40, IR-500, IR-600, IR-700, IRI-600, IRI-600B |
Product
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Reason for recall
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
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-2377-2021. 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.