BOWDOIN, ME – In an update released on November 29, 2024, the FDA has now identified an FHC Inc. recall as Class I, the most serious type, over concerns that a manufacturing size error could result in patient harm.
Initiated on October 3, 2024, the recall covers Lot Number 244517 of FHC Inc.’s microTargeting Insertion Tube Set. The company took action after determining that the production error caused the sets’ reducing cannula (a thin tube used to administer medicine, drain fluids, or insert a surgical instrument by insertion into a vein or body cavity) to measure 20 mm longer than the length printed on the product label.
The FHC microTargeting Insertion Tube Sets are designed to be used during “targeting, functional brain surgery,” or “neurosurgery,” to ensure a microelectrode or instrument is precisely guided in the brain.
While the company has not received any reports of injuries or deaths, consumers are warned that because of this issue, using an affected product could result in a number of severe adverse outcomes: bleeding or hemorrhage, brain tissue damage, and death, among others.
In the initial recall announcement, all impacted customers were sent an Urgent Medical Device Recall letter that outlined the following requests:
- Identify and quarantine all recalled product as soon as possible
- Be on the lookout for an email or phone call from FHC Inc. field representatives. Those affected should expect to receive an RMA for return of all recalled product, and for their set to have been replaced by October 11, 2024 (10/11/2024).
- Refrain, in the mean time, from using any affected product.
U.S. customers were encouraged to reach out to a representative at FHC Inc. via phone at 207-666-8190 regarding any questions about the recall.
Have you or someone you love suffered an adverse health event that can be traced to the manufacturing error of a medical device? We would like to hear you story and help you develop a case for the justice and compensation you deserve. Our knowledgeable attorneys at Oliver Law Office are experienced in a range of mass tort litigation and are prepared to use every resource available to fight on your behalf. Call our office at 614-220-9100 or reach out online to schedule a free, no-risk case review.
