Cordis recalls specific lots of Vista Brite Tip & Androit Guiding Catheters due to frayed mounting card pieces in primary packaging. No remedy is stated in the recall notice.
Frayed pieces of the mounting card being inside the primary packaging.
Cordis is recalling specific lots of Vista Brite Tip & Androit Guiding Catheters because frayed pieces of the mounting card may be inside the primary packaging. This recall does not pose a direct safety risk to users since the catheters are medical devices used by professionals in controlled settings.
The hazard involves frayed pieces of the mounting card being inside the primary packaging. However, the recall does not indicate that these pieces pose a direct risk to users during normal medical procedures. The catheters are designed for professional use in controlled environments.
Healthcare professionals who use these catheters for vascular procedures are most likely affected. The recall targets specific production lots with particular expiration dates.
Check the lot number and expiration date on the packaging. The affected lots are listed in the recall notice with specific expiration dates ranging from 9/30/2020 to 9/30/2021.
Look for the lot number and expiration date on the packaging to determine if your catheters are affected.
The recall is due to frayed pieces of the mounting card being inside the primary packaging, but this does not pose a direct safety risk during normal medical use.
No, the recall does not require stopping use. The hazard is not described as causing injury during normal use.
Check the lot number and expiration date on the packaging. Affected lots are listed in the recall notice with specific expiration dates from 9/30/2020 to 9/30/2021.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1198-2019 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1198-2019 from Cordis. 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.
