ROi CPS LLC Regard Dressing change kit, Item Number 800026006 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard Dressing change kit, Item Number 800026006
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Products Sold
UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
ROi CPS LLC is recalling Regard Dressing change kit, Item Number 800026006 due to ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Recommended Action
Per FDA guidance
ROi 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026