Custom Healthcare Systems recalls two convenience kits due to improper sealing affecting product sterility. Affected kits may not be sterile when used.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling two types of convenience kits because they were sealed with incorrect specifications, which could compromise sterility. This means the kits might not be sterile when used, posing a risk for infections.
The kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility. This means the kits might not be sterile when used, increasing infection risk.
Healthcare workers and others using these kits for medical purposes are most at risk. The kits were sold with specific lot numbers and expiration dates.
Check for product numbers SEPA 402 or SPA502. The kits were sold with lot numbers 72018 (exp. 7/1/2021) or 71118 (exp. 7/1/2021).
Look for product numbers SEPA 402 or SPA502 on the kits.
The kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility.
The recall record does not specify a remedy, so no action is required beyond checking product numbers.
The kits may not be sterile when used due to improper sealing, so they could pose an infection risk.
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-0242-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0242-2019 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.
