STAT 2 Flow Controller — Class I medical device recall Z-2620-2014
Terminated recall by ICU Medical, Inc., reported 2014-10-01, distributed nationwide. ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate tha
| Recall number | Z-2620-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2014-08-19 |
| Classified | 2014-09-19 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2014-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 1,250 units |
| Lot numbers | 2768417 |
| Model numbers | 011-C9802 |
Product
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Reason for recall
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
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-2620-2014. 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.