Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, 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 6,269 units of its Synchro2 0.014-inch by 200cm Standard Pre-Shaped Guidewire with Hydrophilic Coating (Product No. M00326420, REF 2642). The product labels on both the pouch and carton contain an incorrect millimeter measurement for the guidewire's outer diameter, listing 0.036mm instead of the correct value of 0.36mm. The inches dimension listed on the label (0.014 inches) is correct; the millimeter error is a typographical mistake. The affected product has been distributed worldwide, including across all U.S. states and numerous countries.
The recall affects multiple lot numbers manufactured between October 2020 and March 2021. 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: 6269 Lot/code info: UPN: M00326420 Lot Numbers/UDI: 0000000676/ (01)04546540688774(17)201031(10)0000000676; 0000000984/ (01)04546540688774(17)201031(10)0000000984; 0000001019/ (01)04546540688774(17)201031(10)0000001019; 0000001281/ (01)04546540688774(17)201031(10)0000001281; 0000001292/ (01)04546540688774(17)201031(10)0000001292; 0000001498/ (01)04546540688774(17)201031(10)0000001498; 0000001644/ (01)04546540688774(17)201130(10)0000001644; 0000001915/ (01)04546540688774(17)201130(10)0000001915; 0000002059/ (01)04546540688774(17)201130(10)0000002059; 0000002232/ (01)04546540688774(17)201130(10)0000002232; 0000002769/ (01)04546540688774(17)201231(10)0000002769; 0000002977/ (01)04546540688774(17)201231(10)0000002977; 0000002978/ (01)04546540688774(17)201231(10)0000002978; 0000003121/ (01)04546540688774(17)201231(10)0000003121; 0000003122/ (01)04546540688774(17)201231(10)0000003122; 0000003466/ (01)04546540688774(17)210131(10)0000003466; 0000003773/ (01)04546540688774(17)210131(10)0000003773; 0000003952/ (01)04546540688774(17)210131(10)0000003952; 0000004127/ (01)04546540688774(17)210131(10)0000004127; 0000004361/ (01)04546540688774(17)210131(10)0000004361; 0000004644/ (01)04546540688774(17)210228(10)0000004644; 0000004643/ (01)04546540688774(17)210228(10)0000004643; 0000004702/ (01)04546540688774(17)200208(10)0000004702; 0000005894/ (01)04546540688774(17)200310(10)0000005894; 0000005991/ (01)04546540688774(17)210331(10)0000005991; 0000005990/ (01)04546540688774(17)210331(10)0000005990; 0000006201/
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.