Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, 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 107 units of Synchro2 0.014-inch x 300cm SOFT PRE-SHAPED Guidewire with Hydrophilic Coating (Product No. M00326320, REF 2632) due to incorrect labeling on product pouches and cartons. The labels display an incorrect millimeter measurement of 0.036mm for the guidewire outer diameter, when the correct value is 0.36mm. The inches dimension of 0.014 inches shown on the labels is correct. The error is a typographical mistake on the label only and does not affect the actual product specifications.
The affected product was distributed worldwide, including nationwide throughout the United States and multiple countries. The recall involves two lot numbers: 0000001911 and 0000002062. The source document does not specify what action 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: 107 Lot/code info: UPN: M00326320 Lot Numbers/UDI:0000001911/ (01)04546540688750(17)201130(10)0000001911; 0000002062/ (01)04546540688750(17)201130(10)0000002062.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.