Stryker Neurovascular recalls 9F Balloon Guide Catheters due to labeling error where 8F catheters were packaged with 9F. This affects specific lot numbers sold outside the US. No action needed as the product was not distributed in the US.
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Stryker Neurovascular is recalling 9F Balloon Guide Catheters because 8F catheters were mistakenly packaged with them. This labeling error does not pose a safety risk since the affected lot was not distributed in the US and no action is required.
The hazard involves a labeling error where 8F Balloon Guide Catheters were packaged within the 9F packaging. However, this error does not create a safety risk because the affected lot was not distributed in the US.
The recall applies to specific lot numbers of 9F Balloon Guide Catheters that were not distributed in the US. No consumers in the US are affected by this recall.
Check for the lot number 0000010779 on the packaging. The product was not distributed in the US, so no US consumers are affected by this recall.
Look for lot number 0000010779 on the packaging. This lot was not distributed in the US, so no action is needed.
No, the labeling error does not pose a safety risk because the affected lot was not distributed in the US.
No action is needed as the product was not distributed in the US.
The lot number is 0000010779, but this product was not distributed in the US.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2020 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-0065-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
