Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

FDA device recall Z-0524-2021 · posted 2020-12-02 · Terminated

Recall details

Recalling firm

ROi CPS LLC

Reason for recall

Labeling error, incorrect expiration date.

Action taken

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

MLS

Quantity affected

220 kits

Distribution

US Nationwide distribution in the states of MO and OK.

Date initiated

2020-10-12

Date posted

2020-12-02

Date terminated

2021-05-13

Location

Republic, MO