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U.S. Department of Health and Human Services

Class 2 Device Recall STAT 2 I.V. Gravity Flow NeedleFree Controller Primary Administration Sets and Extension Sets

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  Class 2 Device Recall STAT 2 I.V. Gravity Flow NeedleFree Controller Primary Administration Sets and Extension Sets see related information
Date Initiated by Firm June 19, 2017
Create Date February 28, 2018
Recall Status1 Open3, Classified
Recall Number Z-0805-2018
Recall Event ID 79129
510(K)Number K964844  
Product Classification Set, administration, intravascular - Product Code FPA
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. 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.
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
Recalling Firm/
ConMed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact M. Patricia Cotter
Manufacturer Reason
for Recall
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, ConMed, sent an "URGENT: DEVICE RECALL" letter dated 6/21/2017 to its domestic and foreign customers. The letter described the product, the problem and the actions to be taken. The customers were instructed NOT to use any STAT 2¿ I.V. Gravity Flow Controllers manufactured between April 27, 2012 and April 12, 2017; review your inventory for any of the devices listed on Attachment I; contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately; if you HAVE inventory of any of the devices listed, complete the Business Reply Form and return it with devices to: CONMED Corporation, 525 French Road, Utica, NY 13502 via UPS Account # W5Y243; if you DO NOT HAVE any affected devices complete and return the form by email: stat2@conmed.com; fax: Field Action Support Team at 315-624-3225 or US mail to CONMED Corporation, 525 French Road, Utica, NY 13502;Attn: Field Action Support Team. PLEASE DO NOT RETURN USED DEVICES. If you have any questions or requests, please dont hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email stat2@conmed.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = CONMED CORP.