medical Class II Updated 2019-11-06

Stryker Neurovascular recalls Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophili

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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;
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