Custom Healthcare Systems recalls sterile cast padding kits due to improper sealing causing sterility risks. Affected units have product number D4-324SCP and lot 51418.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling sterile cast padding kits that were improperly sealed, risking infection. This affects specific product numbers and lot numbers sold before May 1, 2021.
The kits were sealed in Tyvek pouches using incorrect specifications, which compromised the product's sterility. This could lead to infections if the padding is used without proper sterilization.
People using custom cast padding kits for medical purposes. Those with the specific product number D4-324SCP and lot 51418 are most at risk.
Check for product number D4-324SCP and lot number 51418 on the packaging. The kits were sold with an expiration date of May 1, 2021.
Look for product number D4-324SCP and lot number 51418 on the packaging.
The product number is D4-324SCP.
Lot number 51418 is affected.
The kits were sold with an expiration date of May 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-0245-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0245-2019 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.