Custom Healthcare Systems, Inc. Inpatient Dialysis Kit… recallZ-0863-2020 · Custom Healthcare Systems, Inc. · initiated Dec 20, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Custom Healthcare Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
Custom Healthcare Systems, Inc. sent an "Urgent Medical Device Recall" letter dated January 7, 2020 and email message dated January 9, 2020 to its customer. the letter described the product, problem and actions to be taken. Customer was advised to CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT. Contact John Chou at 804(421-5959) , or email [email protected], with regards to returning affected products. This recall should be carried out to the end user level. If you have distributed the product further, notify your accounts that received the product of this recall. Remaining product you have available for use should be scheduled for return and replacement or credit compensation. Medical Device Recall Return and Receipt Form provided to consignee for completion and return. If you have any further questions, contact Quality Assurance Manager, at 804-421-5959 or email: [email protected]
Recall details
- Recall number
- Z-0863-2020
- Status
- Terminated
- Initiated by the company
- Dec 20, 2019
- Recalling firm
- Custom Healthcare Systems, Inc.
- Quantity
- 240 kits
- Product code
- LRO
- Distribution
- US Distribution to IL.
Product description
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Code information (models, lots, serial numbers)
LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CUSTOM HEALTHCARE SYSTEMS, INC PAK-19244Manus Medical, LLC · General Surgery Tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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