Arrow recalls a specific pacing catheter kit due to being marketed without proper FDA 510K clearance. This device is used in electrophysiology studies. Affected units have specific lot numbers.
Marketed without a 510K
Arrow is recalling a pacing catheter kit that was marketed without FDA 510K clearance. This means the device may not meet safety standards for medical use, potentially risking patient safety during procedures.
The catheter kit was marketed without FDA 510K clearance, which is required for medical devices to ensure safety and effectiveness. This lack of clearance means the device may not meet necessary safety standards for medical use.
Healthcare professionals using this catheter kit for electrophysiology studies are likely affected. Patients undergoing these procedures may be at risk if the device is used without proper clearance.
Check the product code AI-05210 on the kit. Affected units have specific lot numbers: 16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082.
Look for lot numbers listed: 16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082.
The recall states it was marketed without FDA 510K clearance, which means it may not meet safety standards. The official notice does not confirm if it is safe to use.
The recall does not provide a specific remedy, so the official notice does not say what to do.
Check the lot numbers: 16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2068-2021 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2068-2021 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.
