Arrow recalls Percutaneous Sheath Introducer Kits with unsealed packaging that may compromise sterility. Affected units include specific product codes and lot numbers for catheters.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling Percutaneous Sheath Introducer Kits that may have unsealed packaging, risking contamination. This could lead to infections if used in medical procedures.
The packaging may not be sealed properly, which can allow contamination. If the kit is used in medical procedures without proper sterility, it could lead to infections.
Healthcare professionals using the Arrow-Flex Percutaneous Sheath Introducer Kit with specific product codes and lot numbers for catheter procedures. Patients receiving these kits are at risk of infection if the kit is used without proper sterility.
Check for product codes ASK-09903-UM and lot numbers 13F17A0258, 13F17D0075, 13F17G0275, or 13F17L0615. These kits are for use with 7.5-8 Fr. catheters.
Look for product codes ASK-09903-UM and lot numbers 13F17A0258, 13F17D0075, 13F17G0275, or 13F17L0615.
The packaging may not be sealed properly, which can lead to contamination if used in medical procedures.
Check the product codes and lot numbers to see if your kit is affected. If it is, contact Arrow for guidance.
This recall is for potential contamination risk, but the hazard level is low risk as the issue is with packaging, not immediate harm.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1975-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1975-2018 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.
