ROi CPS LLC Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.
Products Sold
Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.
ROi CPS LLC is recalling Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits due to Labeling error, incorrect expiration date.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling error, incorrect expiration date.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026