Custom Healthcare Systems recalls Penrose Drain kits with incorrect sterility packaging. This may compromise medical device sterility during use.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling Penrose Drain kits that were sealed in Tyvek pouches using incorrect specifications. This could compromise the sterility of the medical device, posing a risk during medical procedures.
The kits were sealed in Tyvek pouches with incorrect specifications, which could compromise the sterility of the medical device. This risk exists during medical procedures where sterility is critical.
Healthcare professionals and patients using the recalled Penrose Drain kits for medical procedures. Those with the specific product number D8-9425B are most at risk.
Check for product number D8-9425B and lot number 51418. The kits were sold with an expiration date of May 1, 2021.
Verify the product number D8-9425B and lot number 51418 on the kit packaging.
The recall is due to potential sterility issues with the packaging, which could affect medical procedures if the device is not sterile.
Look for product number D8-9425B and lot number 51418 on the kit packaging.
The recall does not specify a remedy, so contact Custom Healthcare Systems for guidance.
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-0260-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0260-2019 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.
