FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard Custom Procedure Kits containing BD Luer Lok Access Devices
- Recall number
- Z-0837-2022
- Recalling firm
- ROi CPS LLC
- Product
- Regard Custom Procedure Kits containing BD Luer Lok Access Devices
- Status
- Terminated
- Initiated
- 2022-02-24
- Posted
- not on file
- Terminated
- 2022-04-25
- Reason
- Recalled devices were packaged in convenience kits.
- Root cause
- Material/Component Contamination
- Action
- A customer letter dated February 24, 2022 was issued to the impacted consignee. The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers. A reply form should be completed and returned to ROi confirming receipt and understanding of the notification. End users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.
- Quantity
- 1750 kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Lot, serial or model codes
- IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)
- 510(k) numbers
- ["K991088"]
- PMA numbers
- not on file
- Product code
- LRS
- 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