Arrow recalls pressure injectable quad-lumen catheter kits with blue flextip due to potential sterility compromise from unsealed packaging. Affected units include specific product codes and lot numbers.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling pressure injectable quad-lumen catheter kits with blue flextip that may have unsealed packaging, risking sterility. This could lead to infections if the kit is used without proper sterility.
Unsealed packaging may allow contaminants to enter the kit, potentially causing infections during medical procedures. The risk is related to the sterility of the product, not the device itself.
Healthcare professionals using the catheter kits for medical procedures are most at risk. Patients receiving these kits during procedures could be affected if sterility is compromised.
Check for product codes ASK-45854-PSFM or ASK-42854-PRR with specific lot numbers listed in the recall notice. These kits were sold with unsealed packaging that could compromise sterility.
Verify your kit's product code is ASK-45854-PSFM or ASK-42854-PRR with the listed lot numbers.
The recall is due to potential sterility compromise from unsealed packaging, which could lead to infections if the kit is used without proper sterility.
Check your product code and lot numbers against the list provided in the recall notice. If affected, contact Arrow for further instructions.
The recall addresses potential infection risk from compromised sterility, not direct injury from the device.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1991-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1991-2018 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.
