Arrow recalls sheath adapters with Cath-Gard catheter contamination shields 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 sheath adapters with Cath-Gard catheter contamination shields because the packaging may not be sealed properly, risking contamination. This could lead to infections if the device is used in medical procedures.
The sheath adapter's packaging may not be sealed, which could allow contamination. If the device is used in medical procedures without proper sterility, it might lead to infections.
Healthcare professionals using the sheath adapters for catheter procedures are most at risk. Patients receiving procedures with these devices could be affected if contamination occurs.
Check for product codes SA-09847 and lot numbers 13F17B0051, 13F17E0713, 13F17F0767, or 13F17J0010. These adapters are sold for use with 4-7 Fr. catheters.
Look for product codes SA-09847 and lot numbers 13F17B0051, 13F17E0713, 13F17F0767, or 13F17J0010.
The packaging may not be sealed properly, which could lead to contamination if the device is used in medical procedures.
Check the product codes and lot numbers listed. If you have the affected units, you should verify if they are in use and consider contacting Arrow for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2029-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2029-2018 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.
