FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
- Recall number
- Z-1434-2023
- Recalling firm
- ROi CPS LLC
- Product
- Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
- Status
- Open, Classified
- Initiated
- 2023-03-22
- Posted
- 2023-04-25
- Terminated
- not on file
- Reason
- The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.
- Quantity
- 322 kits
- Distribution
- US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OES
- 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