Custom Healthcare Systems recalls convenience kits with incorrect sterility packaging that may compromise product safety. Affected kits have product number D36-16669 and lot 52418, expiring May 1, 2021.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling convenience kits that were sealed in Tyvek pouches with incorrect specifications, which could compromise product sterility. This means the kits might not be safe for medical use.
The kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility. This means the kits might not be safe for medical procedures requiring sterile conditions.
Medical facilities using these kits are likely affected. Patients receiving procedures with these kits face the highest risk due to potential sterility issues.
Check for product number D36-16669 and lot number 52418 on the kit. The kits expire May 1, 2021.
Look for product number D36-16669 and lot number 52418 on the kit.
Product number D36-16669.
May 1, 2021.
Check for product number D36-16669 and lot number 52418 on the kit.
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-0256-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0256-2019 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.
