Z-1255-2022Class II

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

Name: Z-1255-2022 regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Creator: ROi CPS LLC
Published: 2022-05-03
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-05-03 / Terminated

FDA source

ROi CPS LLC began a recall of regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 on 2022-05-03. FDA classified it as Class II and gives the reason as "Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1255-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-03
Posted: 2022-06-09
Terminated: 2022-06-27
Recalling firm: ROi CPS LLC
Product: regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Product code: LRO General Surgery Tray
Reason for recall: Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
FDA 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 [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.
Quantity in commerce: 24 kits
Distribution: FL
Product codes and lots: UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1255-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1255-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-15	2022-06-09

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)