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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 8, 2018 Stryker Neurovascular Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Stryker Neurovascular
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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 Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0231-2020

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