Class 2 Device Recall CHS Custom Convenience Kit

• Date Initiated by Firm: August 13, 2018
• Create Date: October 25, 2018
• Recall Status: Terminated on August 01, 2022
• Recall Number: Z-0248-2019
• Recall Event ID: 81179
• Product Classification: General surgery tray - Product Code LRO
• Product: CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
• Code Information: Lot number: 51418 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: 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: 50 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.