Class I — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. |
| 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. |
| Quantity | 1250 units |
| Distribution | Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa. |
| Initiated | 2014-08-19 |
| Classified | 2014-09-19 |
| Terminated | 2014-11-18 |
| Recall number | Z-2620-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — ICU Medical, Inc. (Z-2620-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69088/
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