Recall Z-0805-2018 ยท FPA Set, Administration, Intravascular
ConMed Corporation
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), 6
| Date | Jun 19, 2017 |
| Status | Terminated |
| Reason | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. |
| Root cause | 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 receiv |
| Quantity | 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 Arab |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964844 | CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS Conmedcorp, Mar 24, 1997 |