Stryker recalls certain Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters with incorrect expiration dates that may cause sterility breaches or treatment delays. Affected units have a one-year shelf life but are labeled as two years.
A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
Stryker is recalling specific Cardiovascular Reprocessed ViewFlex Xtra ICE Catheters that were mislabeled with a two-year expiration date instead of the actual one-year shelf life. Using these catheters could lead to sterility breaches, component failure, or delays in critical medical treatment.
The catheters are labeled with a two-year expiration date when they actually expire after one year. Using them beyond this date could cause sterility breaches, component breakdown, or delays in critical medical procedures.
Healthcare professionals using the recalled catheters for cardiovascular procedures are most at risk. Patients receiving treatment with these catheters may face complications due to potential sterility issues or treatment delays.
Check for the product name 'Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter', size 9F (3.2mm), length 90 cm, and the unique identifiers listed in the recall notice. The earliest affected units expire in May 2020.
Verify the expiration date on the catheter's packaging or label; if it shows two years instead of one year, it is affected.
If the catheter has an incorrect expiration date, stop using it immediately and contact Stryker for further instructions.
The catheters were mislabeled with a two-year expiration date instead of the actual one-year shelf life, which could lead to sterility breaches or treatment delays.
Check the expiration date on the catheter; if it shows two years instead of one year, stop using it immediately and contact Stryker for further instructions.
The earliest affected units expire in May 2020, but the actual shelf life is one year from the date of manufacture.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2113-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2113-2020 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.
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.
