Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551

Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Code information: SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.