FDA Medical Device Recalls (openFDA)
ROi CPS LLC: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
- Recall number
- Z-0411-2022
- Recalling firm
- ROi CPS LLC
- Product
- regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
- Status
- Terminated
- Initiated
- 2021-11-04
- Posted
- 2021-12-22
- Terminated
- 2023-08-07
- Reason
- The kit contains a non-sterile needle.
- Root cause
- Process control
- Action
- The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer. The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution. The attached reply form was to be completed so that return of the affected kits could be arranged. If the kits were further distributed, the customer was requested to notify their customers.
- Quantity
- 40 kits
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLS
- 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