Z-0524-2021Class II

Regard -

Name: Z-0524-2021 Regard -
Creator: ROi CPS LLC
Published: 2020-10-12
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2020-10-12 / Terminated / root cause: labeling and UDI

FDA source

ROi CPS LLC began a recall of Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits on 2020-10-12. FDA classified it as Class II and gives the reason as "Labeling error, incorrect expiration date". 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-0524-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-12
Posted: 2020-12-02
Terminated: 2021-05-13
Recalling firm: ROi CPS LLC
Product: Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Product code: MLS Labor And Delivery Kit
Reason for recall: Labeling error, incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: ROi CPS, LLC issued the recall in the form of customer notices sent through email on 10/12 2020. The customer recall notices required that the consignees review their inventory and segregate the affected kits, so a correction of affected kits can be coordinated . Kits reported to ROi CPS, LLC will be reworked to correct the labeling on each kit prior to releasing back to the consignees. ROi CPS, LLC requested that consignees forward the recall notice to any other users who may have received the affected kits. As of the date of this letter, no product has been returned to ROi CPS, LLC, we will continue to monitor responses from the distribution center and the end user. Kits that are reported will be quarantined and then reworked to correct the labeling prior to releasing back to the end user.
Quantity in commerce: 220 kits
Distribution: US Nationwide distribution in the states of MO and OK.
Product codes and lots: Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0524-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0524-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-02

Product code MLS

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)