FDA Medical Device Recalls (openFDA)
ROi CPS LLC: regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
- Recall number
- Z-1295-2022
- Recalling firm
- ROi CPS LLC
- Product
- regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
- Status
- Terminated
- Initiated
- 2022-05-20
- Posted
- 2022-06-28
- Terminated
- 2023-05-02
- Reason
- A nonsterile component was packaged in a sterile convenience kit.
- Root cause
- Process change control
- Action
- The recalling firm called the consignee on 5/20/2022 to discuss the recall, including quarantine of affected product, customer fulfilment/available inventory, end user facility notification, recall timelines, and establishing a plan for relabeling by the recalling firm personnel at the distribution center. The recalling firm issued an email to the consignee on 5/20/2022 with an attached recall notice that was previously discussed with the consignee. The email requested the consignee to quarantine the kits and immediately notify the end user facilities who have been shipped the affected kits. In the email, the recalling firm reported they would be sending someone to the direct account and to the end user facilities to complete the correction of the affected kits. The attached letter dated 5/20/22 informed the customer of the reason for recall, health risk assessment, and the actions to be taken by customers. The letter contained a picture of the non-sterile Ultrasound Gel that is to be discarded from the kits. A Recall Reply Form was enclosed to indicate the quantity of product in the customer's possession. The customer was also supposed to indicate that they have read and understand the notice and it has been forwarded to all customers who have been shipped the affected product.
- Quantity
- 180 kits
- Distribution
- US Nationwide distribution in the state of FL.
- Lot, serial or model codes
- Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
- 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