Stryker recalls Synchro2 guidewires with incorrect outer diameter labeling (0.036mm instead of 0.014in). This could lead to improper use in medical procedures. Affected units include specific product numbers and 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 due to a labeling error that shows an incorrect outer diameter measurement (0.036mm instead of 0.014in). This error could lead to improper use during medical procedures if the wrong size is selected. The recall affects specific product numbers and lot numbers.
The label shows an incorrect outer diameter measurement (0.036mm) instead of the correct 0.014in (0.36mm). This typographical error could lead to selecting the wrong size guidewire during medical procedures, potentially causing complications.
Healthcare professionals using the recalled guidewires for neurovascular procedures are most at risk. Patients receiving these guidewires during surgery may be affected if the incorrect size is used.
Check for the product name 'Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating' on the label or packaging. Affected units have specific product numbers (M00326520) and lot numbers listed in the recall notice.
Look for the product name and lot numbers on the label or packaging to confirm if it is affected.
The product labels show an incorrect outer diameter measurement (0.036mm) instead of the correct 0.014in (0.36mm). This is a typographical error that could lead to improper use during medical procedures.
Check the product label for the specific lot numbers and product numbers listed in the recall notice. If affected, contact Stryker for further instructions.
The recall indicates a labeling error that could lead to improper use, but the hazard is described as a typographical error without mention of actual injury risk.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0232-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0232-2020 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.
