Custom Healthcare Systems recalls 10-pack formula caps (product UNC-9538) due to improper sterility sealing. Affected units expire Feb 2021. No remedy specified in recall notice.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling 10-pack formula caps (product number UNC-9538) because they were sealed with incorrect specifications, which could compromise product sterility. This means the caps might not be sterile when used, posing a risk of contamination during medical procedures.
The caps were sealed in Tyvek pouches using incorrect specifications, which compromises their sterility. This could lead to contamination during medical procedures if the caps are not properly sterile.
Healthcare providers using these caps for medical procedures are most at risk. Patients receiving treatments with contaminated equipment could face infection.
Check for product number UNC-9538 on the packaging. The lot number is 51418 and the expiration date is February 1, 2021.
Look for product number UNC-9538 on the packaging with lot number 51418 and expiration date February 1, 2021.
The caps were sealed in Tyvek pouches using incorrect specifications, which compromises product sterility.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected product.
The product was sold with an expiration date of February 1, 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-0258-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0258-2019 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.
