Summary
The FDA issued a Class II for Stainless Steel Sims Uterine Sound, Part Number 64-601 by CooperSurgical, Inc.. Reason: During the manufacturing process the devices were laser-marked with the incorrect part number..
Details
Source
Device Recall
External ID
Z-3189-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Stainless Steel Sims Uterine Sound, Part Number 64-601
Lot/Code Info: UDI-DI: 00888937017779; Part Numbers: 64-600
Quantity Affected: 657 units
Reason for Recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-31
Company
Trumbull, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperSurgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc. have FDA actions?
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3189-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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