FDA Medical Device Recalls (openFDA)
ROi CPS LLC: regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
- Recall number
- Z-1255-2022
- Recalling firm
- ROi CPS LLC
- Product
- regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
- Status
- Terminated
- Initiated
- 2022-05-03
- Posted
- not on file
- Terminated
- 2022-06-27
- Reason
- Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
- Root cause
- Other
- Action
- ROI notified the sole consignee with a MEDICAL DEVICE RECALL NOTICE by email on 05/03/2022. The letter explained the problem and requested the following actions: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the item/lot number listed in the above table are in your inventory. 2. HOLD: Quarantine all affected kits in your inventory and do not further distribute or use. 3. REPLY: Complete the recall reply form attached to this notice and return to lacy.stewart@roiscsc.com. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. 4. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this recall notice. You may include a copy of this notice as well as the notice issued by Medline to supplement your communication.
- Quantity
- 24 kits
- Distribution
- FL
- Lot, serial or model codes
- UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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