Arrow recalls Blue PSI kits with integral hemostasis valve for catheters due to unsealed packaging potentially compromising sterility. Affected units include specific product codes and lot numbers.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling Blue PSI kits used with catheters because the packaging might not be sealed properly, which could lead to contamination. This means the medical device might not be sterile when used, posing a risk during procedures.
The packaging isn't sealed properly, which could let contaminants enter the kit. This might make the device not sterile when used, increasing the risk of infection during medical procedures.
Healthcare professionals using the kit with 7-7.5 Fr. catheters are most likely affected. Patients receiving procedures with this kit could be at risk if the device isn't sterile.
Check for product codes SF-29803-1 and lot numbers 13F17C0004 or 13F17G0030 on the kit packaging. The kit is designed for use with 7-7.5 Fr. catheters.
Look for product codes SF-29803-1 and lot numbers 13F17C0004 or 13F17G0030 on the kit.
The recall states sterility may be compromised due to unsealed packaging, so it is not safe to use as is.
The recall does not specify a remedy, so check with Arrow International for guidance.
Look for product codes SF-29803-1 and lot numbers 13F17C0004 or 13F17G0030 on the kit packaging.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2031-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2031-2018 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.
