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U.S. Department of Health and Human Services

Class 2 Device Recall CHS Custom Convenience Kit

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  Class 2 Device Recall CHS Custom Convenience Kit see related information
Date Initiated by Firm August 13, 2018
Create Date October 25, 2018
Recall Status1 Terminated 3 on August 01, 2022
Recall Number Z-0246-2019
Recall Event ID 81179
Product Classification General surgery tray - Product Code LRO
Product CHS Custom Convenience Kit-PAD, COTTON SINGLE
Product Number:R1178
Code Information Lot number: 52418 Exp. Date: 5/1/2021  
Recalling Firm/
Manufacturer		 Custom Healthcare Systems, Inc.
4205 Eubank Rd
Richmond VA 23231-4328
Manufacturer Reason
for Recall		 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
FDA Determined
Cause 2		 Packaging
Action Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.
Quantity in Commerce 160 units
Distribution Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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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