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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Dressing Change Tray

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  Class 2 Device Recall Regard Dressing Change Tray see related information
Date Initiated by Firm March 26, 2021
Create Date May 07, 2021
Recall Status1 Terminated 3 on January 30, 2023
Recall Number Z-1542-2021
Recall Event ID 87658
Product Classification Dressing change tray - Product Code OXQ
Product Regard Dressing Change Tray
Code Information Lot Numbers: 86983C, 87081C and 86356C.
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Cheyenne Lacy Stewart
417-730-3900
Manufacturer Reason
for Recall		 ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
FDA Determined
Cause 2		 Package design/selection
Action On March 26, 2021 the firm sent a notification to customers: Actions to be taken by customers: 1. CHECK: please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. ACT: If the affected kits are identified, immediately quarantine. Use the attached Avery label template to label the affected kits. Place the label in a location where it is clearly visible. The label instructs the end user to remove the ChloraPrep from the kit and pull from sterile supply. 3. REPLY: Please complete the attached reply form indicating any inventory on hand. If you do not have inventory, please return the form indicating 0 affected inventory at your facility. It is important that we promptly receive your completed reply form. 4. NOTIFY: This notice is to be sent to end user facilities who were shipped the affected kits. Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include copy of this notice and the attached label template with your customer notification. 5. END USERS: Notices sent to end users should instruct that the ChloraPrep contained within the kits be removed and discarded.
Quantity in Commerce 272 trays
Distribution US Nationwide distribution in the state of Louisiana.
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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