Custom Healthcare Systems recalls inpatient dialysis kits PAK-19244 with latex in a component that wasn't labeled. This may cause allergic reactions. Contact for replacement.
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.
Custom Healthcare Systems is recalling inpatient dialysis kits PAK-19244 because a component contains latex that wasn't labeled on the product. This could cause allergic reactions in sensitive individuals.
The dialysis kit contains a component (1961 TELFA PAD 2 X 3) with latex that wasn't labeled on the product. This could cause allergic reactions in people sensitive to latex.
Patients using inpatient dialysis kits PAK-19244 with latex in a component that wasn't labeled. Those with latex allergies are at higher risk.
Check for the lot number 20190614 on the kit, which expires February 1, 2020. The product is labeled as PAK-19244.
Look for the 1961 TELFA PAD 2 X 3 component in the dialysis kit.
The recall states the component contains latex but wasn't labeled, so it may cause allergic reactions in sensitive individuals.
Check for the lot number 20190614 on the kit, which expires February 1, 2020.
The recall does not specify a remedy, so contact the manufacturer for information.
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-0863-2020 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0863-2020 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.