Arrow recalls Radial Artery Catheterization Kit model AK-04120 with povidone iodine prep pads that expire after 24 months instead of 36. Affected kits were sold from October 2018 to 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 Kit model AK-04120 because the included povidone iodine prep pads expire after 24 months, not the standard 36 months. This means the pads could become less effective over time, potentially increasing the risk of infection during medical procedures.
The povidone iodine prep pads in certain kits expire after 24 months instead of the required 36 months. This means the pads may not be as effective at preventing infection over time, especially if used beyond their expiration date.
Healthcare professionals using the kit for radial artery catheterizations are most at risk. Patients receiving procedures with these kits could also be affected if the pads become less effective.
Check for the model AK-04120 on the kit. Kits sold between October 2018 and March 2020 are affected, with specific lot numbers listed in the recall notice.
Look for the model AK-04120 on the kit and verify the lot numbers: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163.
The povidone iodine prep pads in these kits do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Check the kit for the model AK-04120 and lot numbers listed in the recall notice. If you have the affected kit, contact Arrow International for guidance.
The pads may become less effective over time, potentially increasing the risk of infection during medical procedures if used beyond their expiration date.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1284-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1284-2018 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.
