Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Reason for recall: Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. Distribution: Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Quantity: 183 Lot/code info: Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371
00690103219388, 00690103219289, 00690103219371
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.