Arrow recalls bipolar electrode catheters with incorrect expiration dates. Products labeled with wrong use-by date may expire before intended use. Consumers should check product labels for correct expiration date.
Products are labeled with an incorrect expiration date
Arrow is recalling bipolar electrode catheters that have an incorrect expiration date label. This could mean the product expires before it's supposed to, potentially causing issues if used after the wrong date.
The catheter has an incorrect expiration date label, which could lead to the product expiring before it's intended to be used. This might cause the catheter to be used after it's no longer safe or effective.
Users of Arrow electrophysiology catheters for temporary heart studies may be affected. Those who have the product with the specific model and batch number are most at risk.
Check for the product code AI-062:10-S and batch number 16F18A0010 on the catheter label. The expiration date should be 2023-12-31 as per the label.
Verify the expiration date on the catheter label matches the use-by date of 2023-12-31.
The catheter has an incorrect expiration date label, which could cause it to expire before intended use.
Check the expiration date on the label. If it's incorrect, contact Arrow for guidance.
The recall is due to an incorrect expiration date label, not an immediate safety hazard. Using it after the wrong date could lead to ineffective use.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-3197-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-3197-2018 from Arrow. 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.