Z-0805-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- June 19, 2017
- Termination Date
- July 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,612,440in total
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.
Reason for Recall
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Distribution Pattern
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.
Code Information
Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124; (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074; and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134