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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Custom Surgical Pack

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  Class 2 Device Recall Regard Custom Surgical Pack see related information
Date Initiated by Firm September 25, 2017
Create Date November 21, 2017
Recall Status1 Open3, Classified
Recall Number Z-0169-2018
Recall Event ID 78377
Product Classification General surgery tray - Product Code LRO
Product Regard Custom Surgical Pack

Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Code Information Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803-6317
For Additional Information Contact
417-820-2793
Manufacturer Reason
for Recall		 Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.
FDA Determined
Cause 2		 Error in labeling
Action Customer was notified of the recall via email on September 25, 2017. Instructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793
Quantity in Commerce 51 units
Distribution Distributed domestically to Texas.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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