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U.S. Department of Health and Human Services

Class 2 Device Recall 2 MHZ Waterproof OB Probe

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  Class 2 Device Recall 2 MHZ Waterproof OB Probe see related information
Date Initiated by Firm October 06, 2017
Create Date March 19, 2018
Recall Status1 Terminated 3 on February 06, 2020
Recall Number Z-1131-2018
Recall Event ID 79213
510(K)Number K024197  
Product Classification Monitor, ultrasonic, fetal - Product Code KNG
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.
Code Information SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact James Keller-
203-601-9812
Manufacturer Reason
for Recall		 The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
FDA Determined
Cause 2		 Error in labeling
Action CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200.
Quantity in Commerce 13 units
Distribution Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNG and Original Applicant = SUMMIT DOPPLER SYSTEMS, INC.
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