Custom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
Custom Healthcare Systems is recalling 240 inpatient dialysis kits because a component contains latex that was not listed on the product labels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a missing allergen label (latex) for a high-risk patient population (dialysis patients), which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 240 units of the Inpatient Dialysis Kit (PAK-19244). The recall was initiated because a component included in the kit, specifically a 1961 TELFA PAD 2 X 3, contains latex. The case label and device label for the product did not indicate that the kit contained latex.
The affected products are identified by Lot Number 20190614 and have an expiration date of February 1, 2020. The Unique Device Identifier (UDI) for the product is (01)00811870033261(17)200201(10)20190614. The agency classifies this recall as Class II.
The affected kits were distributed in the United States to Illinois. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the unlisted latex poses a risk to individuals with latex allergies.
The recalled product
- Product
- Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Dialysis
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- LOT NUMBER: 20190614
- expires February 1
- 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
Distribution
Distributed in 1 state:
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