Custom Healthcare Systems recalls convenience kits with improper sterility sealing. Products may cause infection if used. Stop using immediately.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling convenience kits that were sealed with incorrect specifications, which could compromise sterility. This risk of infection means users should stop using the kits immediately.
The kits were sealed in Tyvek pouches using incorrect specifications, which could allow contamination. This compromises the sterility of the medical devices inside, increasing infection risk during procedures.
Healthcare workers and patients using the recalled convenience kits are at risk of infection due to compromised sterility.
Check for product number B9-15934B and lot number 70618 with an expiration date of September 1, 2020.
Discard the recalled convenience kit to prevent infection risk.
Product number B9-15934B.
Lot number 70618 with an expiration date of September 1, 2020.
The recall does not provide a fix; users must stop using and discard the kits.
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-0240-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0240-2019 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.
