Device product

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

Z-0863-2020

December 20, 2019

Class II

Product summary

Firm: Custom Healthcare Systems, Inc.
Event: Event 84693
Status: Terminated
Classification: Class II
Quantity: 240 kits
Official record key: device-enforcement:Z-0863-2020

Official wording

Reason: 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.

Code information: LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614

Distribution pattern: US Distribution to IL.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.