Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, 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 is recalling 305 units of Synchro2 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating (UPN M00326520, REF 2652) distributed worldwide, including all U.S. states and multiple countries. The product labels on the pouch and carton contain an incorrect measurement for the Guidewire Outer Diameter, listing 0.036mm when the correct value is 0.36mm. The inches dimension on the label (0.014in) is correct, and the millimeter figure represents a typographical error.
The recall affects six specific lot numbers with expiration dates ranging from December 2020 through April 2021. The source document does not specify what consumers or healthcare facilities should do with affected product.
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: 305 Lot/code info: UPN: M00326520 Lot Numbers/UDI: 0000002431/ (01)04546540688798(17)201231(10)0000002431; 0000002645/ (01)04546540688798(17)201231(10)0000002645; 0000002771/ (01)04546540688798(17)201231(10)0000002771; 0000006204/ (01)04546540688798(17)210331(10)0000006204; 0000006875/ (01)04546540688798(17)210401(10)0000006875; 0000007429/ (01)04546540688798(17)210430(10)0000007429;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.