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U.S. Department of Health and Human Services

Class 1 Device Recall Regard

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 Class 1 Device Recall Regardsee related information
Date Initiated by FirmNovember 20, 2023
Date PostedJanuary 03, 2024
Recall Status1 Terminated 3 on August 05, 2024
Recall NumberZ-0596-2024
Recall Event ID 93525
Product Classification Dressing change tray - Product Code OXQ
ProductRegard Dressing change kit, Item Number 800026006
Code Information UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact
417-730-3900
Manufacturer Reason
for Recall		ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionROi CPS issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 11/27/2023 via email. The notice explained the problem, potential risk, and requested the following actions: 1. CHECK: Please review your inventory to determine if the manufacturer item number and lot numbers listed in the above table are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits listed above. Do not further distribute. 3. REMOVE: The affected Cardinal Health item 1022-(100ML Sterile Saline Irrigation bottle), attached to the outside of the affected kits as a piggy back prior to use or further distribution. The remainder of the kit is not affected and can be distributed/used after the 100 ML Saline Irrigation Bottle is removed. 4. REPLY: Please indicate your understanding and completion of the instructions above by completing and returning the attached reply form. a. Complete the section confirming destruction of the sterile saline irrigation bottles removed from the outside of the kit, if applicable, and discard according to your institution's disposal procedures. b. Complete and return the reply form even if you do not have any affected inventory at your facility to acknowledge receipt of the notices. c. Please return the reply form to lacy.stewart@roiscs.com. 5. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from Cardinal Health, and the initial recall issued by Nurse Assist in your communication. 6. END USERS: End user facilities are to follow the instructions above and complete and return the reply form indicating their understanding and compliance with the required actions, including the destruction of the Sterile Saline Irrigation Bottles.
Quantity in Commerce1830 units
DistributionUS Nationwide distribution in the state of Louisiana.
Total Product Life CycleTPLC 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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