Device Recall STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration and Extension set

Catalog Number, Manufacturing Date range, Lot Code range: (1) S2, 4/27/12 - 2/1/17, 120427X - 201702014; (2) S2-12, 4/27/12 - 3/13/17, 120427X - 201703134; (3) S2-20 MD, 4/27/12 - 1/2/17, 120427X - 201701024; (4) S2V-20, 4/27/12 - 4/7/17, 120427X - 201704074; and (5) S2V-60, 4/27/12 - 3/16/17, 120427X - 201703164

General Hospital and Personal Use Devices

2

No

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.

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.