Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, 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 its Synchro2 0.014 inch x 200cm SOFT Guidewire with Hydrophilic Coating due to incorrect labeling on product pouches and cartons. The labels display an incorrect millimeter measurement of 0.036mm for the guidewire's outer diameter, when the correct value is 0.36mm. The inch measurement of 0.014 inches shown on the labels is accurate. This labeling error represents a typographical mistake.
Approximately 13,503 units have been distributed worldwide, including across all U.S. states and multiple countries. The affected products are identified by UPN M00326010 and multiple lot numbers ranging from 0000000558 through 0000003120. The source document does not specify a remedy or recommended action for affected consumers.
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: 13503 Lot/code info: UPN: M00326010 Lot Numbers/UDI:0000000558 /(01)04546540688729(17)201031(10)0000000558; 0000000560/ (01)04546540688729(17)201031(10)0000000560; 0000000671/ (01)04546540688729(17)201031(10)0000000671; 0000000672/ (01)04546540688729(17)201031(10)0000000672; 0000000980/ (01)04546540688729(17)201031(10)0000000980; 0000000987/ (01)04546540688729(17)201031(10)0000000987; 0000001013/ (01)04546540688729(17)201031(10)0000001013; 0000001014/ (01)04546540688729(17)201031(10)0000001014; 0000001275/ (01)04546540688729(17)201031(10)0000001275; 0000001274/ (01)04546540688729(17)201031(10)0000001274; 0000001276/ (01)04546540688729(17)201031(10)0000001276; 0000001287/ (01)04546540688729(17)201031(10)0000001287; 0000001285/ (01)04546540688729(17)201031(10)0000001285; 0000001492/ (01)04546540688729(17)201031(10)0000001492; 0000001286/ (01)04546540688729(17)201031(10)0000001286; 0000001493/ (01)04546540688729(17)201031(10)0000001493; 0000001909/ (01)04546540688729(17)201130(10)0000001909; 0000001910/ (01)04546540688729(17)201130(10)0000001910; 0000002053/ (01)04546540688729(17)201130(10)0000002053; 0000002054/ (01)04546540688729(17)201130(10)0000002054; 0000002425/ (01)04546540688729(17)201231(10)0000002425; 0000002639/ (01)04546540688729(17)201231(10)0000002639; 0000002638/ (01)04546540688729(17)201231(10)0000002638; B47912/ (01)04546540688729(17)200930(10)B47912; 0000002764/ (01)04546540688729(17)201231(10)0000002764; 0000002765/ (01)04546540688729(17)201231(10)0000002765; 0000003120/ (01)04546
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.