Stryker recalls Synchro2 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating due to incorrect millimeter label (0.036mm listed instead of 0.36mm). This could lead to improper use during medical procedures. Affected units include specific lot numbers.
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 because the product labels incorrectly list the outer diameter as 0.036mm instead of the correct 0.36mm. This labeling error could lead to improper use during medical procedures if the guidewire is used with the wrong size catheter.
The label shows an incorrect millimeter value (0.036mm) for the guidewire's outer diameter, when the correct value is 0.36mm. This typographical error could lead to using the guidewire with a catheter that is too small, potentially causing blockages or other complications during procedures.
Medical professionals who use the Synchro2 guidewires for intravascular procedures may be affected. Patients receiving these guidewires during procedures are at risk if the incorrect size causes complications.
Check the product label for the outer diameter dimension. The correct value is 0.014in (0.36mm). Affected units have the product code M00326410 and specific lot numbers listed in the recall notice.
Verify the outer diameter dimension on the product label is 0.014in (0.36mm) instead of 0.036mm.
The product labels incorrectly list the outer diameter as 0.036mm instead of the correct 0.36mm, which is a typographical error.
Check the label for the correct outer diameter dimension (0.014in or 0.36mm). If the label shows 0.036mm, it is affected and should be checked with a healthcare provider.
Yes, specific lot numbers are listed in the recall notice, including 0000000564 through 0000009017.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0229-2020 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-0229-2020 from Stryker Neurovascular. 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.
