Arrow recalls Radial Artery Catheterization Kit model AK-04220 with povidone iodine prep pads that expire after 24 months instead of 36. Affected kits have specific lot numbers and expiration dates.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Arrow is recalling certain Radial Artery Catheterization Kits (model AK-04220) because the included povidone iodine prep pads expire after 24 months, not the standard 36 months. This could lead to ineffective disinfection if used past their expiration date.
The povidone iodine prep pads in these kits have a shorter shelf life than required. If used after their expiration date, they may not disinfect properly, potentially increasing infection risk during medical procedures.
Healthcare professionals using the specific model kits with lot numbers 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, or 23F16J0018. Patients receiving procedures using these kits may be at risk if the pads expire.
Check for the model number AK-04220 on the kit. Look for lot numbers: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, or 23F16J0018. The expiration dates range from October 2018 to March 2020.
Verify the expiration date on the povidone iodine prep pads; they should not be past their 24-month expiration date.
The povidone iodine prep pads in certain kits expire after 24 months instead of the required 36 months, which could lead to ineffective disinfection.
Model AK-04220 with lot numbers 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, or 23F16J0018.
No, but you should check the expiration date on the povidone iodine pads. If expired, replace them with new pads that have a 36-month shelf life.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1286-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1286-2018 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.