FDAClass IIOctober 2, 2024

Stainless Steel Sims Uterine Sound recall

Stainless Steel Sims Uterine Sound, Part Number 64-601

Why was Stainless Steel Sims Uterine Sound recalled?

During the manufacturing process the devices were laser-marked with the incorrect part number.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00888937017779; Part Numbers: 64-600

Product
Stainless Steel Sims Uterine Sound, Part Number 64-601
Recalling firm
CooperSurgical, Inc.
Quantity
657 units
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Recall date
October 2, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls