Arrow recalls temporary pacing catheter kits marketed without FDA 510K clearance for electrophysiology studies. Affected units have specific lot numbers and product codes.
Marketed without a 510K
Arrow is recalling temporary pacing catheter kits that were sold without proper FDA approval. This means the devices may not be safe for medical use as intended.
The devices were marketed without FDA 510K clearance, which is required for medical devices that interact with the body. This means the devices may not meet safety standards for use in medical procedures.
Medical professionals using these catheter kits for electrophysiology studies are likely affected. Patients receiving these procedures may be at risk if the devices are used without proper clearance.
Check for product code AI-06210-IK on the kit. Lot numbers 16F20C0035 and 16F20F0124 are associated with this recall.
Look for product code AI-06210-IK on the catheter kit.
The devices were marketed without FDA 510K clearance, which is required for medical devices used in procedures.
The recall record does not specify a remedy, so contact Arrow International for guidance.
Lot numbers 16F20C0035 and 16F20F0124 are affected.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2069-2021 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2069-2021 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.
