Arrow recalls Radial Artery Catheterization Kit (AK-04018) with povidone iodine prep pads that expire after 24 months instead of 36. This affects kits sold between October 2018 and March 2020.
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 Radial Artery Catheterization Kits (model AK-04018) because the included povidone iodine prep pads have a 24-month shelf life instead of the required 36 months. This means the pads could become ineffective or unsafe after their expiration date, potentially leading to improper disinfection during medical procedures.
The povidone iodine prep pads in these kits expire after 24 months instead of the required 36 months. This means the pads may lose effectiveness over time, potentially leading to inadequate disinfection during medical procedures if used after their expiration date.
Healthcare professionals using the specific model kits (AK-04018) sold between October 2018 and March 2020 are most at risk. Patients receiving procedures using these kits could be affected if the pads expire.
Check for the model number AK-04018 on the kit packaging. The kits were sold between October 2018 and March 2020 with specific lot numbers listed in the recall notice.
Verify the expiration date on the povidone iodine prep pads; they should not exceed 24 months from the date of manufacture.
The povidone iodine prep pads in these kits do not meet the required 36-month shelf life and should be labeled with a 24-month shelf life.
The recall notice does not specify a remedy, so check the expiration date on the pads and ensure they are used within 24 months of manufacture.
The recall does not state that using expired pads causes injury, but they may become ineffective, potentially leading to inadequate disinfection during medical procedures.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1281-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1281-2018 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.