Arrow recalls 5Fr catheter clamps with fastener (product code CC-00005) due to unsealed packaging potentially compromising sterility. Affected units include specific lot numbers from 2013.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling 5Fr catheter clamps with fastener (product code CC-00005) because the packaging may not be sealed properly, risking contamination during medical procedures. This could lead to infections if the device is used without proper sterility.
The unsealed packaging means the catheter clamp might become contaminated during storage or handling. If used without proper sterility, this could lead to infections in medical procedures.
Healthcare professionals using the device for medical procedures are most at risk. Patients receiving treatments with this device could face infection if sterility is compromised.
Check for the product code CC-00005 on the device. Affected units include specific lot numbers starting with 13F17 (e.g., 13F17A0198).
Inspect the packaging for any signs of being unsealed or damaged.
The recall indicates the packaging may not be sealed properly, which could compromise sterility. Do not use if the packaging appears unsealed.
Affected lot numbers include 13F17A0198, 13F17C0056, 13F17D0135, 13F17D0236, 13F17F0075, 13F17F0600, 13F17G0179, 13F17H0107, 13F17H0367, and 13F17J0198, 13F17K0212.
The recall record does not specify a remedy or replacement process.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2007-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2007-2018 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.
