Custom Healthcare Systems recalls CHS Custom Convenience Kit-CONNECTOR PACK (D36-7520) due to improper sterility packaging. Affected units expire May 2021. No remedy specified in recall notice.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling their CHS Custom Convenience Kit-CONNECTOR PACK (product number D36-7520) because the packaging used incorrect specifications that compromised product sterility. This could lead to infections if the kit is used for medical purposes.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which compromised the product's sterility. This means the kits could become contaminated and cause infections if used for medical procedures.
Healthcare professionals and medical facilities that purchased the CHS Custom Convenience Kit-CONNECTOR PACK (product number D36-7520) between the time of manufacture and expiration date of May 2021. Those using the kit for medical procedures are at higher risk.
Check for product number D36-7520 on the kit. The lot number is 51418 and the expiration date is May 1, 2021. The kits were sold with the product name 'CHS Custom Convenience Kit-CONNECTOR PACK'.
Look for product number D36-7520, lot number 51418, and expiration date May 1, 2021 on the kit.
The recall notice states the kits were sealed with incorrect specifications that compromised sterility, so they are not safe for medical use.
The recall notice does not specify a remedy, so contact Custom Healthcare Systems for guidance.
The product was manufactured with an expiration date of May 1, 2021.
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-0255-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0255-2019 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.
