Custom Healthcare Systems recalls CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER (Product 01-375C) due to improper sterility packaging that could compromise medical safety. Affected units expire June 1, 2021.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling their CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER (Product Number 01-375C) because the packaging used incorrect specifications, which could compromise sterility. This risk could lead to infections during medical procedures if the kit is used without proper sterilization.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which compromises product sterility. This means the kit may not be sterile when opened, increasing the risk of infection during medical procedures.
Healthcare professionals and medical facilities that use this needle holder kit are most at risk, particularly those who rely on the kit for procedures requiring sterile conditions.
Check for Product Number 01-375C and Lot number 61918 on the packaging. The kit expires June 1, 2021.
Look for Product Number 01-375C and Lot number 61918 on the packaging.
The recall states the packaging may compromise sterility, so it is not safe to use without proper sterilization.
The recall does not specify a remedy, so contact Custom Healthcare Systems for guidance.
The kit expires June 1, 2021, as indicated on the packaging.
We’ve drafted a message you can send Custom Healthcare Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0252-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0252-2019 from Custom Healthcare Systems. 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.
