Stryker recalls Synchro2 guidewires with incorrect outer diameter label (0.036mm instead of 0.36mm). This could lead to improper use in 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 an incorrect label showing 0.036mm instead of 0.36mm for the outer diameter. This error could cause improper use during medical procedures if the wrong size is used.
The label incorrectly states the outer diameter as 0.036mm (which is 0.0014 inches) instead of the correct 0.36mm (0.014 inches). This discrepancy could lead to using a guidewire that is too small for the intended procedure, potentially causing complications.
Medical professionals using these guidewires for intravascular procedures are affected. The risk is low as the error is a labeling mistake, not a physical defect.
Check for the product code M00326420 and lot numbers listed in the recall notice. The guidewires are labeled as 0.014in x 200cm STANDARD PRE-SHAPED with hydrophilic coating.
Look for the outer diameter label on the pouch or carton. The correct value is 0.36mm (0.014 inches), not 0.036mm.
The product labels contain an incorrect value (0.036mm) for the outer diameter, which should be 0.36mm. This is a typographical error.
This is a labeling error that could lead to improper use if the wrong size is selected, but it does not cause immediate harm or physical damage.
Check the product code M00326420 and lot numbers listed in the recall notice, which include specific sequences like 0000000676 to 0000007907.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0230-2020 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.
