Arrow recalls 9 Fr. Radiopaque Polyurethane Sheaths with unsealed packaging that may compromise sterility. Affected units include specific product codes and lot numbers.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling 9 Fr. Radiopaque Polyurethane Sheaths that may have unsealed packaging, risking contamination. This could lead to infections if used in medical procedures.
The sheaths may have unsealed packaging, which can allow contamination. If the packaging is compromised, the sterile product may not be safe for medical use.
Medical professionals using these sheaths for catheter procedures are most at risk. Patients receiving procedures with these sheaths could face infection.
Check for product code SS-09903-S or lot numbers starting with 13F17H0405. These sheaths are used with 7-8 Fr. catheters in medical procedures.
Look for product code SS-09903-S or lot numbers starting with 13F17H0405.
Unsealed packaging may compromise sterility, potentially leading to infections if used in medical procedures.
Check for product code SS-09903-S or lot numbers starting with 13F17H0405.
The recall does not require immediate stop use; check the product code or lot number to confirm if affected.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2032-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2032-2018 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.
