Arrow International recalls specific lots of Arrowg+ard Blue PSI kits for catheters due to potential sterility issues. Affected units may not be sealed properly, risking infection during medical procedures.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Arrow International is recalling certain lots of Arrowg+ard Blue PSI kits used with specific catheter sizes because they may not seal properly, which could lead to contamination during medical procedures. This affects patients receiving these catheters and requires immediate attention to prevent infection risks.
The kits may not seal completely, which means the catheters could become contaminated during medical procedures. This contamination could lead to infections in patients if the kits are used without proper sterility.
Patients receiving the recalled Arrowg+ard Blue PSI kits for catheter procedures are most at risk. Healthcare providers using these kits with 7-7.5 Fr. or 7.5-8 Fr. catheters may also be affected.
Check for lot numbers 13F17D0188 or 13F17E0570 on the Arrowg+ard Blue PSI kit for 7-7.5 Fr. catheters, and lot number 13F17E0660 for 7.5-8 Fr. catheters. The kits have part numbers ASK-29804-UHN2 or ASK-29903-UCD.
Look for lot numbers 13F17D0188, 13F17E0570, or 13F17E0660 on the kit packaging.
The kits may not seal completely, which could lead to contamination during medical procedures and increase infection risk for patients.
Check for lot numbers 13F17D0188, 13F17E0570, or 13F17E0660 on the Arrowg+ard Blue PSI kit for 7-7.5 Fr. catheters (part number ASK-29804-UHN2) or 7.5-8 Fr. catheters (part number ASK-29903-UCD).
The recall does not require immediate discontinuation; however, affected kits should be checked for lot numbers and replaced if necessary.
We’ve drafted a message you can send Arrow International to request your refund or repair — edit it as you like.
Subject: Recall Z-1334-2018 — Arrow International Arrow International Hello, I own a Arrow International that is covered by recall Z-1334-2018 from Arrow International. 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.
