FDA recall Z-1131-2018

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-10-06

Report date

2018-03-28

Termination date

2020-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2018