CooperSurgical, Inc. recalls Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use i…

Recall date

October 6, 2017

Source

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

Recall number

Z-1131-2018

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

Why it was recalled

The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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

What was recalled

Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.