COOPERSURGICAL Os FinderTM Cervical Dilator recalled over labeling errors

Recall date

June 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CooperSurgical, Inc. recalls COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

Recall number

Z-2498-2020

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Nationwide

Why it was recalled

Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176