Stryker recalls Synchro2 guidewires with incorrect outer diameter label (0.036mm instead of 0.36mm). This could lead to improper use during medical procedures. Affected units include specific lot numbers and product codes.
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.
Stryker is recalling certain Synchro2 guidewires that have a label error showing an incorrect outer diameter measurement (0.036mm instead of 0.36mm). This could lead to improper use during medical procedures if the wrong size is used.
The label shows an incorrect outer diameter measurement (0.036mm) instead of the correct 0.36mm. This typographical error could lead to using the wrong size guidewire during medical procedures, potentially causing complications.
Healthcare professionals using these guidewires for neurovascular or peripheral vascular procedures. Patients receiving these guidewires during medical treatments are at risk if the incorrect size is used.
Check for the product name 'Synchro2', 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO. Look for specific lot numbers listed in the recall notice.
Verify the outer diameter measurement on the label is 0.36mm (not 0.036mm) as the correct value.
The product labels contain a typographical error showing an incorrect outer diameter measurement (0.036mm) instead of the correct 0.36mm.
Check for the product name 'Synchro2', 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO. The specific lot numbers listed in the recall notice are affected.
No, but you should verify the label measurement to ensure it's 0.36mm (not 0.036mm) before use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0225-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0225-2020 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
