Stryker recalls eco reprocessed electrophysiology catheters (item # D134903) that are not approved for reprocessing, which could lead to improper use.
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Stryker is recalling reprocessed electrophysiology catheters (item # D134903) because they were mistakenly labeled as approved for reprocessing when they are not. This could lead to unsafe medical use if used without proper validation.
These catheters were incorrectly labeled as approved for reprocessing (item # D134903) when they are actually item # D134909, which is not approved. Using them without proper validation could lead to unsafe medical procedures.
Healthcare professionals using these catheters for cardiac mapping procedures. Patients receiving procedures with improperly reprocessed catheters may face risks.
Check for item number D134903 on the catheter packaging or labels. These catheters were sold with serial numbers 2519054 and 2534027.
Look for item number D134903 on the catheter packaging or labels.
No, these catheters are not approved for reprocessing and may be unsafe if used without proper validation.
The recall record does not specify a remedy, so contact Stryker directly for guidance.
They were mistakenly labeled as approved for reprocessing when they are actually item # D134909, which is not approved for reprocessing.
We’ve drafted a message you can send Stryker Sustainability Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0467-2019 — Stryker Sustainability Solutions Stryker Sustainability Solutions Hello, I own a Stryker Sustainability Solutions that is covered by recall Z-0467-2019 from Stryker Sustainability Solutions. 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.
