Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, 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 Synchro2 0.014-inch guidewires with hydrophilic coating because the product labels on the pouches and cartons contain an incorrect millimeter measurement for the guidewire's outer diameter. The labels show 0.036mm, which is a typographical error; the correct outer diameter is 0.36mm. The inch measurement of 0.014 inches shown on the labels is correct. Approximately 21,971 units have been distributed worldwide, including throughout all U.S. states and multiple countries.
The affected products are identified by UPN M00326410, REF 2641, and specific lot numbers ranging from 0000000564 through 0000001914. The source document does not specify any remedy or action that affected consumers should take.
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: 21971 Lot/code info: UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688767(17)201031(10)0000000565; 0000000566/(01)04546540688767(17)201031(10)0000000566; 0000000673/ (01)04546540688767(17)201031(10)0000000673; 0000000674/ (01)04546540688767(17)201031(10)0000000674; 0000000675/ (01)04546540688767(17)201031(10)0000000675; 0000000983/ (01)04546540688767(17)201031(10)0000000983; 0000000982/ (01)04546540688767(17)201031(10)0000000982; 0000001016/ (01)04546540688767(17)201031(10)0000001016; 0000001017/ (01)04546540688767(17)201031(10)0000001017; 0000001018/ (01)04546540688767(17)201031(10)0000001018; 0000001280/ (01)04546540688767(17)201031(10)0000001280; 0000001279/ (01)04546540688767(17)201031(10)0000001279; 0000001278/ (01)04546540688767(17)201031(10)0000001278; 0000001289/ (01)04546540688767(17)201031(10)0000001289; 0000001290/ (01)04546540688767(17)201031(10)0000001290; 0000001291/ (01)04546540688767(17)201031(10)0000001291; 0000001495/ (01)04546540688767(17)201031(10)0000001495; 0000001497/ (01)04546540688767(17)201031(10)0000001497; 0000001496/ (01)04546540688767(17)201031(10)0000001496; 0000001640/ (01)04546540688767(17)201130(10)0000001640; 0000001641/ (01)04546540688767(17)201130(10)0000001641; 0000001642/ (01)04546540688767(17)201130(10)0000001642; 0000000989/ (01)04546540688767(17)201031(10)0000000989; 0000001912/ (01)04546540688767(17)201130(10)0000001912; 0000001913/ (01)04546540688767(17)201130(10)0000001913; 0000001914/ (
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.