Custom Healthcare Systems recalls 10-pack cotton tip applicators (product R1112B) due to improper sterility packaging. Affected units may cause infection if used.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling 10-packs of cotton tip applicators because they were sealed in Tyvek pouches with incorrect specifications, which compromises sterility. Using these products could lead to infections if they are not properly sterile.
The applicators were sealed in Tyvek pouches using incorrect specifications, which compromises product sterility. This means the items may not be sterile when used, increasing the risk of infection.
Healthcare professionals and medical facilities that use these cotton tip applicators are most at risk. Individuals using the products for medical purposes may be affected.
Check for product number R1112B and lot number 52418. The expiration date is May 1, 2021. These items were sold as 10-packs of cotton tip applicators.
Verify the product number (R1112B) and lot number (52418) on the packaging.
The recall states the products may not be sterile due to improper packaging, so they should not be used until the recall is addressed.
Check the product number and lot number to confirm if they are affected. If they match, stop using them and contact the manufacturer.
The products were sold 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-0243-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0243-2019 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.
