Custom Healthcare Systems recalls suture removal kits with incorrect sterility packaging. Affected kits may not be sterile, risking infection during medical procedures.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling suture removal kits that were sealed in Tyvek pouches with incorrect specifications, which could compromise product sterility. This means the kits might not be sterile when used, increasing infection risk during medical procedures.
The kits were sealed in Tyvek pouches using incorrect specifications, which compromises product sterility. This means the kits may not be sterile when used, potentially leading to infections during medical procedures.
Healthcare professionals who use these kits for suture removal are most at risk. Patients receiving procedures with these kits could face infection.
Check for product number UNC-9481B and lot number 51018. The kits were sold with an expiration date of February 1, 2021, or May 1, 2021.
Look for product number UNC-9481B and lot number 51018 on the kit packaging.
Custom Healthcare Systems is recalling suture removal kits that were sealed in Tyvek pouches with incorrect specifications, which could compromise product sterility.
Check for product number UNC-9481B and lot number 51018. The kits were sold with an expiration date of February 1, 2021, or May 1, 2021.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
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-0259-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0259-2019 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.