FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard brand CABG Pack A and B - Spartanburg
- Recall number
- Z-1051-2022
- Recalling firm
- ROi CPS LLC
- Product
- Regard brand CABG Pack A and B - Spartanburg
- Status
- Terminated
- Initiated
- 2022-03-21
- Posted
- not on file
- Terminated
- 2023-12-28
- Reason
- Kits were packed into shipping boxes incorrectly.
- Root cause
- Under Investigation by firm
- Action
- An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs.com so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
- Quantity
- 85 kits
- Distribution
- Recall impacted one domestic consignee in NC
- Lot, serial or model codes
- Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- 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