FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard Dressing Change Tray
- Recall number
- Z-1542-2021
- Recalling firm
- ROi CPS LLC
- Product
- Regard Dressing Change Tray
- Status
- Terminated
- Initiated
- 2021-03-26
- Posted
- not on file
- Terminated
- 2023-01-30
- Reason
- ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
- Root cause
- 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
- 272 trays
- Distribution
- US Nationwide distribution in the state of Louisiana.
- Lot, serial or model codes
- Lot Numbers: 86983C, 87081C and 86356C.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28