Z-0469-2022Class II

Regard, T AND A - Rogers, sterilized convenience kits

Name: Z-0469-2022 Regard, T AND A - Rogers, sterilized convenience kits
Creator: ROi CPS LLC
Published: 2021-11-30
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-11-30 / Terminated / root cause: labeling and UDI

FDA source

ROi CPS LLC began a recall of Regard, T AND A - Rogers, sterilized convenience kits on 2021-11-30. FDA classified it as Class II and gives the reason as "Kits lacks rubber latex warning label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0469-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-30
Posted: 2022-01-10
Terminated: 2023-08-07
Recalling firm: ROi CPS LLC
Product: Regard, T AND A - Rogers, sterilized convenience kits
Product code: OGR Ear, Nose, And Throat Surgical Tray
Reason for recall: Kits lacks rubber latex warning label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A customer notification email dated 11/30/2021 was sent with recall instructions as follows: 1. Check: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the table are in your inventory. 2. Quarantine: If the affected kits are identified, please quarantine the product and do not further distribute. 3. Label Affected kits: Use the label template attached to this notice to label affected kits in your inventory prior to shipping to customers. The label includes the statement "This kit contains a URETHRAL CATHETER RED RUBBER 12FR that contains natural rubber latex which may cause allergic reactions." The label should be placed in a location on the outer wrapper of the kits that is visible to end users. 4. Reply: Please complete the attached reply form indicating any inventory on hand at your facility. If you do not have inventory, please return the form indicating "0" inventory on hand. 5. Notify: Please immediately notify any customers to who, you have distributed or forwarded kits affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 6. End users: Notices sent to end users should include the label template and instruction to label affected kits in their inventory. The label should be placed in a location on the outer wrapper of the kits that is visible to users of the kits.
Quantity in commerce: 195 kits
Distribution: US Nationwide distribution in the state of MO.
Product codes and lots: 1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-10

Product code OGR

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)