Custom Healthcare Systems recalls large surgical gown sets due to improper sealing in Tyvek pouches, risking contamination. Affected units sold with specific product numbers and lot dates.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling large surgical gown sets that were sealed in Tyvek pouches with incorrect specifications, which could compromise sterility. This poses a risk of infection during surgical procedures if the gowns are used without proper sterilization.
The gowns were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility. This means the gowns might not be sterile when used in surgical procedures, increasing the risk of infection for patients.
Surgical staff and healthcare facilities that purchased the recalled gowns with product number 1231-050L and lot numbers W72018 or W71218. Patients undergoing surgery are at risk if the gowns are used without proper sterilization.
Check for product number 1231-050L and lot numbers W72018 or W71218 on the packaging. The gowns were sold with an expiration date of July 1, 2021.
Verify the product number and lot numbers on the packaging to confirm if the gown is affected.
The recall states that the gowns were sealed with incorrect specifications, which could compromise sterility. They are not safe for surgical use without proper sterilization.
The recall record does not specify a remedy, so there is no action required beyond checking if the gown is affected.
The gowns were sold with an expiration date of July 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-0264-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0264-2019 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.
