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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

CooperSurgical, Inc.: Sims Uterine Sounds Recalled for Incorrect Laser-Marked Part Numbers

Agency Publication Date: September 20, 2024
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Summary

CooperSurgical, Inc. is recalling 1,125 units of Sims Uterine Sounds, including both Silver-Plated Copper and Stainless Steel models. These medical instruments were laser-marked with incorrect part numbers during the manufacturing process, which can lead to confusion during surgical preparation or inventory management. The recall affect 468 silver-plated units and 657 stainless steel units distributed worldwide.

Risk

The incorrect part numbers marked on the devices may lead to the selection of the wrong instrument material or size during a procedure, potentially causing surgical delays or improper use. No specific injuries have been reported, but the error creates a risk of clinical confusion during medical interventions.

What You Should Do

  1. Identify if you have the affected devices by checking the laser-marked part numbers and packaging. Look for 'Silver-Plated Copper Sims Uterine Sound' labeled as Part Number 64-600 (UDI-DI: 00888937017762).
  2. Check for 'Stainless Steel Sims Uterine Sound' marked as Part Number 64-601, but note that the device itself may incorrectly display Part Number 64-600 (UDI-DI: 00888937017779).
  3. Immediately isolate any affected products to ensure they are not used in clinical procedures.
  4. Contact your healthcare provider or CooperSurgical, Inc. directly at their Trumbull, CT location to arrange for the return or replacement of the mislabeled devices.
  5. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Model / REF:
64-600
UPC Codes:
00888937017762
Product: Stainless Steel Sims Uterine Sound, Part Number 64-601
Model / REF:
64-601
64-600
UPC Codes:
00888937017779

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95232
Status: Active
Manufacturer: CooperSurgical, Inc.
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (468 units; 657 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.