Stainless Steel Sims Uterine Sound, Part Number 64-601

FDA device recall Z-3189-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

CooperSurgical, Inc.

Reason for recall

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

Action taken

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 Recall@coopersurgical.com 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 Recall@coopersurgical.com. You may also reach us at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 17:00 M-F EDT.

Root cause

Process control

Status

Open, Classified

Product code

HHM

Quantity affected

657 units

Distribution

Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.

Date initiated

2024-07-31

Date posted

2024-09-20

Location

Trumbull, CT