Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, 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 2,421 units of its Synchro2 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating due to incorrect labeling. The product labels on both the pouch and carton contain a typographical error in the Guidewire Outer Diameter dimension, listing 0.036mm when the correct value is 0.36mm. The inches measurement of 0.014in shown on the label is accurate. The product was distributed worldwide, including throughout the United States and multiple countries.
The recall affects specific lot numbers manufactured between October 2020 and April 2021. The source document does not specify what actions affected consumers should take in response to this recall.
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: 2421 Lot/code info: UPN: M00326510 Lot Numbers/UDI:0000000985/ (01)04546540688781(17)201031(10)0000000985; 0000001020/ (01)04546540688781(17)201031(10)0000001020; 0000001499/ (01)04546540688781(17)201031(10)0000001499; 0000001916/ (01)04546540688781(17)201130(10)0000001916; 0000001645/ (01)04546540688781(17)201130(10)0000001645; 0000002060/ (01)04546540688781(17)201130(10)0000002060; 0000002061/ (01)04546540688781(17)201130(10)0000002061; 0000002979/ (01)04546540688781(17)201231(10)0000002979; 0000003123/ (01)04546540688781(17)201231(10)0000003123; 0000003771/ (01)04546540688781(17)210131(10)0000003771; 0000003772/ (01)04546540688781(17)210131(10)0000003772; 0000003953/ (01)04546540688781(17)210131(10)0000003953; 0000004128/ (01)04546540688781(17)210131(10)0000004128; 0000004362/ (01)04546540688781(17)210131(10)0000004362; 0000005992/ (01)04546540688781(17)210331(10)0000005992; 0000006203/ (01)04546540688781(17)210331(10)0000006203; 0000006318/ (01)04546540688781(17)210331(10)0000006318; 0000006483/ (01)04546540688781(17)210331(10)0000006483; 0000006621/ (01)04546540688781(17)210331(10)0000006621; 0000006828/ (01)04546540688781(17)210401(10)0000006828; 0000006622/ (01)04546540688781(17)210331(10)0000006622; 0000007003/ (01)04546540688781(17)210430(10)0000007003; 0000007094/ (01)04546540688781(17)210430(10)0000007094; 0000007249/ (01)04546540688781(17)210411(10)0000007249; 0000007428/ (01)04546540688781(17)210430(10)0000007428;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.