Recall record at a glance
| Official record | Z-0805-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ConMed Corporation |
| Report date | Mar 7, 2018 |
| Recall initiation date | Jun 19, 2017 |
| Quantity | 1,612,440in total |
| Location | Utica, NY, United States |
Official product description
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. 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.
Why the product was recalled
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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