STAT 2¿ I — Class II medical device recall Z-0804-2018
Terminated recall by ConMed Corporation, reported 2018-03-07, distributed nationwide. Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
| Recall number | Z-0804-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2017-06-19 |
| Classified | 2018-02-28 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2022-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, IN, LB, PA, SA |
| Quantity | 1,612,440 in |
Product
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.
Reason for recall
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Machine access
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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.