Z-1542-2021Class II

Regard Dressing Change Tray

Name: Z-1542-2021 Regard Dressing Change Tray
Creator: ROi CPS LLC
Published: 2021-03-26
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-03-26 / Terminated / root cause: packaging

FDA source

ROi CPS LLC began a recall of Regard Dressing Change Tray on 2021-03-26. FDA classified it as Class II and gives the reason as "ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1542-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-26
Posted: 2021-05-07
Terminated: 2023-01-30
Recalling firm: ROi CPS LLC
Product: Regard Dressing Change Tray
Product code: OXQ Dressing Change Tray
Reason for recall: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On March 26, 2021 the firm sent a notification to customers: Actions to be taken by customers: 1. CHECK: please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. ACT: If the affected kits are identified, immediately quarantine. Use the attached Avery label template to label the affected kits. Place the label in a location where it is clearly visible. The label instructs the end user to remove the ChloraPrep from the kit and pull from sterile supply. 3. REPLY: Please complete the attached reply form indicating any inventory on hand. If you do not have inventory, please return the form indicating 0 affected inventory at your facility. It is important that we promptly receive your completed reply form. 4. NOTIFY: This notice is to be sent to end user facilities who were shipped the affected kits. Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include copy of this notice and the attached label template with your customer notification. 5. END USERS: Notices sent to end users should instruct that the ChloraPrep contained within the kits be removed and discarded.
Quantity in commerce: 272 trays
Distribution: US Nationwide distribution in the state of Louisiana.
Product codes and lots: Lot Numbers: 86983C, 87081C and 86356C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1542-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1542-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-07

Product code OXQ

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)