—#161417

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964844
Affected lot / code info: 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

Why it was recalled

Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

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.

Timeline

Recall initiated: 2017-06-19
Terminated: 2022-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161417. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.