FDA recall Z-3189-2024

CooperSurgical, Inc. · Class II · device

Product

Stainless Steel Sims Uterine Sound, Part Number 64-601

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.

Key facts

Status
Ongoing
Initiation date
2024-07-31
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3189-2024