Z-0863-2020Class II

Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

Name: Z-0863-2020 Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Creator: Custom Healthcare Systems, Inc.
Published: 2019-12-20
License: https://open.fda.gov/license/

Manus Medical, LLC / initiated 2019-12-20 / Terminated / root cause: labeling and UDI

FDA source

Custom Healthcare Systems, Inc. began a recall of Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit on 2019-12-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0863-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-20
Posted: 2020-01-24
Terminated: 2022-08-01
Recalling firm: Manus Medical, LLC
Product: Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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]
Quantity in commerce: 240 kits
Distribution: US Distribution to IL.
Product codes and lots: LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0863-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0863-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)