Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Reason: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information: UPN: M00326110 Lot Numbers/UDI: 0000000562/ (01)04546540688736(17)201031(10)0000000562; 0000001015/ (01)04546540688736(17)201031(10)0000001015; 0000001277/ (01)04546540688736(17)201031(10)0000001277; 0000001288/ (01)04546540688736(17)201031(10)0000001288; 0000001494/ (01)04546540688736(17)201031(10)0000001494; 0000000981/ (01)04546540688736(17)201031(10)0000000981; 0000002055/ (01)04546540688736(17)201130(10)0000002055; 0000002239/ (01)04546540688736(17)201130(10)0000002239; 0000002973/ (01)04546540688736(17)201231(10)0000002973; 0000003130/ (01)04546540688736(17)201231(10)0000003130; 0000003131/ (01)04546540688736(17)201231(10)0000003131; 0000003464/ (01)04546540688736(17)210131(10)0000003464; 0000003949/ (01)04546540688736(17)210131(10)0000003949; 0000003680/ (01)04546540688736(17)200112(10)0000003680; 0000004124/ (01)04546540688736(17)210131(10)0000004124; 0000005456/ (01)04546540688736(17)200227(10)0000005456; 0000005986/ (01)04546540688736(17)210331(10)0000005986; 0000006197/ (01)04546540688736(17)210331(10)0000006197; 0000006198/ (01)04546540688736(17)210331(10)0000006198; 0000006313/ (01)04546540688736(17)210331(10)0000006313; 0000006479/ (01)04546540688736(17)210331(10)0000006479; 0000006968/ (01)04546540688736(17)210407(10)0000006968; 0000007088/ (01)04546540688736(17)210430(10)0000007088; 0000007635/ (01)04546540688736(17)210421(10)0000007635; 0000007423/ (01)04546540688736(17)210430(10)0000007423; 0000007636/ (01)04546540688736(17)210421(10)0000007636; 0000007851/ (01)04546540688736(17)210425(10)0000007851.

Distribution pattern: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.