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U.S. Department of Health and Human Services

Class 2 Device Recall PAK19244 INPATIENT DIALYSIS KIT

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  Class 2 Device Recall PAK19244 INPATIENT DIALYSIS KIT see related information
Date Initiated by Firm December 20, 2019
Create Date January 24, 2020
Recall Status1 Terminated 3 on August 01, 2022
Recall Number Z-0863-2020
Recall Event ID 84693
Product Classification General surgery tray - Product Code LRO
Product Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use.

Dialysis kit
Code Information LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
Recalling Firm/
Manufacturer		 Custom Healthcare Systems, Inc.
4205 Eubank Rd
Richmond VA 23231-4328
For Additional Information Contact John Chou
804-421-5959
Manufacturer 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.
FDA Determined
Cause 2		 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 j.chou@customhealthcaresystems.com, 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: j.chou@customhealthcaresystem.com
Quantity in Commerce 240 kits
Distribution US Distribution to IL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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