Custom Healthcare Systems recalls CHS Custom Convenience Kit-PAD, COTTON SINGLE (Product R1178) due to improper sealing in Tyvek pouches compromising sterility. Affected units expire May 2021.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling their Cotton Single Convenience Kit-PAD (Product R1178) because it was sealed in Tyvek pouches with incorrect specifications, which could compromise product sterility. This recall affects units produced with Lot Number 52418 that expire May 2021.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility. This means the kits might not be sterile when used, potentially leading to infections or contamination in medical procedures.
Healthcare professionals and facilities using this kit for medical purposes are most at risk due to potential sterility issues. The recall applies to specific units with Lot Number 52418 that expire May 2021.
Check for Product Number R1178 and Lot Number 52418 on the kit. The kits expire May 2021 and were sold with specific packaging that may not meet sterility standards.
Look for Product Number R1178 and Lot Number 52418 on the kit to confirm it is affected.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which could compromise product sterility.
The recall does not specify a remedy, so check the product details to see if it is affected and contact Custom Healthcare Systems for further instructions.
The affected kits have Lot Number 52418 and expire May 2021.
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-0246-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0246-2019 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.
