AVID Medical recalls Halyard CPT BASIC IR PACK model 1646381 due to potential open header bag seals compromising sterility. Affected units sold until January 2028.
Potential for open header bag seals, compromising sterility.
AVID Medical is recalling Halyard CPT BASIC IR PACK convenience kits because the packaging might open, making them no longer sterile. This could lead to infections during medical procedures if used improperly.
The header bag seals on the product might open during storage or handling, which could compromise the sterility of the device. This poses a risk of infection if the device is used without proper sterility.
Healthcare professionals using this medical device for procedures are most at risk. Patients receiving treatments with this device could be affected if the packaging is compromised.
Check for model number 1646381 on the packaging. The product was sold with a UDI of 10809160363256 and expires January 31, 2028.
Look for model number 1646381 and expiration date of January 31, 2028 on the packaging.
The recall states the packaging might open, compromising sterility. If the packaging is not compromised, it may be safe, but the manufacturer recommends checking for the specific model and expiration date.
Check for model number 1646381 on the packaging. The product was sold with a UDI of 10809160363256 and expires January 31, 2028.
The recall does not specify a remedy, so you should check the product packaging for the model number and expiration date to determine if it's affected.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2531-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-2531-2025 from AVID Medical. 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.
