Arrow recalls Percutaneous Sheath Introducer Kits with unsealed packaging that may compromise sterility. Affected kits include specific product codes and lot numbers for 7.5-8 Fr. 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 unsealed packaging may allow contaminants to enter the kit, compromising sterility. This could lead to infections during medical procedures if the kit is used without proper sterilization.
Healthcare professionals using the kit with 7.5-8 Fr. catheters are most at risk. Patients receiving procedures with these kits could be affected if the kit is contaminated.
Check for product code ASK-09903-UPA and lot numbers 13F17E0762, 13F17F0599, 13F17H0058, 13F17J0241, 13F17L0114, or 13F17L0485.
Verify the product code and lot numbers to confirm if your kit is affected.
The unsealed packaging may compromise sterility, risking contamination during medical procedures.
The recall does not specify a remedy, so check the product details to see if it's affected.
Look for product code ASK-09903-UPA and lot numbers 13F17E0762, 13F17F0599, 13F17H0058, 13F17J0241, 13F17L0114, or 13F17L0485.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1976-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1976-2018 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.
