Sims Uterine Sound recallZ-3188-2024 · CooperSurgical, Inc. · initiated Jul 31, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA root cause category: Process control
What the company is doing
An 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 [email protected] 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 [email protected]. You may also reach us at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 17:00 M-F EDT.
Recall details
- Recall number
- Z-3188-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2024
- Posted by the FDA
- Sep 20, 2024
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 468 units
- Product code
- HHM
- Distribution
- Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Product description
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Code information (models, lots, serial numbers)
UDI-DI: 00888937017762; Part Numbers: 64-600
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sims Uterine Sound 64-600Coopersurgical, Inc. · Sound, Uterine1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95232).
- Z-3189-2024 · Open, ClassifiedStainless Steel Sims Uterine Sound, Part Number 64-601
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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