PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 9, 2020 Initiated: October 12, 2020 #Z-0524-2021

Product Description

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

Reason for Recall

Labeling error, incorrect expiration date.

Details

Recalling Firm
ROi CPS LLC
Units Affected
220 kits
Distribution
US Nationwide distribution in the states of MO and OK.
Location
Republic, MO

Frequently Asked Questions

What product was recalled?
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.. Recalled by ROi CPS LLC. Units affected: 220 kits.
Why was this product recalled?
Labeling error, incorrect expiration date.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0524-2021.