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U.S. Department of Health and Human Services

Class 2 Device Recall Stainless Steel Sims Uterine Sound

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 Class 2 Device Recall Stainless Steel Sims Uterine Soundsee related information
Date Initiated by FirmJuly 31, 2024
Date PostedSeptember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3189-2024
Recall Event ID 95232
Product Classification Sound, uterine - Product Code HHM
ProductStainless Steel Sims Uterine Sound, Part Number 64-601
Code Information UDI-DI: 00888937017779; Part Numbers: 64-600
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactKaren Gienau
203-601-5200
Manufacturer Reason
for Recall		During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA Determined
Cause 2		Process control
ActionAn URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE notification letter dated 7/31/24 was sent to customers. Actions to be Taken: For CUSTOMERS and DISTRIBUTORS: " Inspect your inventory for any of this Product. Product Number and other information can be found on the box and package labeling. " Please complete the included Customer Acknowledgment Form and send it via email to Recall@coopersurgical.com to complete this action. For CUSTOMERS: " If your clinic or health system has multiple locations, and you wish to report for multiple physical locations, please indicate which physical locations in the response. For DISTRIBUTORS: " If the Product has been distributed to your customers, send a copy of this letter and the Customer Acknowledgement Form to each of these customers. Please report any adverse events to your local Regulatory Authority as well as to CooperSurgical. Our email address is Recall@coopersurgical.com. You may also reach us at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 17:00 M-F EDT.
Quantity in Commerce657 units
DistributionWorldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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