regard GS0098C - RESUSABLE RT BRONCH, Item Number:… recallZ-1255-2022 · ROi CPS LLC · initiated May 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
FDA root cause category: Other
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-1255-2022
- Status
- Terminated
- Initiated by the company
- May 3, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 24 kits
- Product code
- LRO
- Distribution
- FL
Product description
regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Code information (models, lots, serial numbers)
UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ GS00986CRoi Cps, LLC · General Surgery Tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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