Class II — ConMed Corporation
| Recalling firm | CONMED CORPORATION |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. |
| Product | STAT 2® I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2® Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2® Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2® Primary Administration Set Gravity Flow Controller (Needle-Free), 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. T… |
| Quantity | 1,612,440in total |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada. |
| Initiated | 2017-06-19 |
| Classified | 2018-02-28 |
| Terminated | 2022-07-25 |
| Recall number | Z-0805-2018 |
| 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 II recall — ConMed Corporation (Z-0805-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79129/
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