FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Recall number
- Z-0315-2024
- Recalling firm
- ROi CPS LLC
- Product
- Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Status
- Open, Classified
- Initiated
- 2023-09-21
- Posted
- 2023-11-16
- Terminated
- not on file
- Reason
- Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
- Root cause
- Other
- Action
- ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email. The email attached the notice and the notice received from Getinge. The notice explained the issue, the potential risks, and requested the distributor notify their customer. End user was directed to post the Getinge notice in area where the affect kits were used. An updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions.
- Quantity
- 134 units
- Distribution
- MO
- Lot, serial or model codes
- a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
- 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