Custom Healthcare Systems recalls two vaginal speculum kits due to improper sealing in Tyvek pouches, risking contamination. Affected kits have specific product numbers and expiration dates.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling two vaginal speculum kits because they were sealed in Tyvek pouches using incorrect specifications, which could compromise sterility. This means the kits might not be sterile when used, increasing infection risk during medical procedures.
The kits were sealed in Tyvek pouches with incorrect specifications, which could lead to contamination. This means the speculums might not be sterile when used, potentially causing infections during medical procedures.
Medical professionals and individuals using these kits for gynecological exams. Those with the specific product numbers and expiration dates listed are most at risk.
Check for product numbers D36-16267 (small) or D36-16269 (large). The kits were sold with lot numbers 51418 or 52418 and expire by May 1, 2021.
Look for product numbers D36-16267 (small) or D36-16269 (large) on the kit packaging.
The kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility.
The kits might not be sterile when used, increasing the risk of infection during medical procedures.
Check for product numbers D36-16267 (small) or D36-16269 (large) with lot numbers 51418 or 52418 and 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-0249-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0249-2019 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.
