Recall Z-1131-2018— CooperSurgical, Inc.

Name: FDA recall Z-1131-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-06

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2017-10-06, terminated 2020-02-06. It names one FDA 510(k) clearance: K024197. 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: The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Terminated: 2020-02-06
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K024197 — LIFEDOP DOPPLERSummit Doppler Systems, Inc.·cleared 2003-01-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.