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.
Check against the official notice below — it lists the full affected range.
Stryker Neurovascular has recalled Synchro2 0.014-inch by 200-centimeter soft pre-shaped guidewires with hydrophilic coating due to incorrect labeling. The product labels on both the pouch and carton contain a typographical error listing the outer diameter as 0.036mm, when the correct measurement is 0.36mm. The inches dimension of 0.014 inches printed on the label is accurate. Approximately 3,720 units were distributed worldwide, including throughout the United States and multiple countries.
The recall affects specific lot numbers distributed between October 2019 and April 2021. According to the recall record, no remedy or action is specified for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Cze Quantity: 3720 Lot/code info: 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/
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.