FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard Kit containing the Microtek decanter
- Recall number
- Z-2685-2024
- Recalling firm
- ROi CPS LLC
- Product
- Regard Kit containing the Microtek decanter
- Status
- Open, Classified
- Initiated
- 2024-06-17
- Posted
- 2024-08-16
- Terminated
- not on file
- Reason
- Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- Root cause
- Pending
- Action
- The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.
- Quantity
- 78 Kits
- Distribution
- US Nationwide distribution in the state of MO.
- Lot, serial or model codes
- Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPE
- 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