Medical Device Recalls

We Provide Regulatory Solutions

Through customized return solutions, comprehensive reporting, and compliant product destruction, IoMT Recycling Solutions helps manufacturers successfully complete medical device recalls, corrections, and device removals.

Medical devices play a crucial role in patient care, but occasionally, issues may arise that necessitate a product recall. While the U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness of these devices, we provide the regulatory solution for medical device recalls.

Recall Strategy

Once a recall has been initiated, the manufacturer’s recall strategy must include a planned course of action to alert the public. In addition, medical device recall strategies must include “the degree to which the product remains in the market-place” and “continued availability of the essential product”. (Code of Federal Regulation, Title 21, Volume 1, Part 7, Section 7.42 Recall Strategy)

Your status reports to the FDA must show the number of products returned and destroyed. In fact, the manufacturer must retain all records for a period of two years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.

IoMT Solutions destruction reports will provide the documentation you need to provide to the FDA and will eliminate any risks to the public.

For an actual client example of IoMT recall management capabilities, see this case study.

IoMT Recycling Solutions Reporting

For over 30 years, we have been providing comprehensive product destruction and recycling reports. As a certified facility, we document every item we receive, including the client information, the container information, the container seal, the product description, serial number, quantity, and any other necessary information that you require.

“The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal.”

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices#5

Any Document | Any Time | Any Project

Our Compliance Library makes it easy to retrieve any document at any time from any project.

In 2010 we introduced our web based document archive “Compliance Library ™” and have steadily improved the accessibility and ease of use of this service.  Therefore, now we provide all project documentation such as bills of lading, project quotes, project invoices and relevant project emails.

The Compliance Library™ identifies the location and date of the specific event. It is fully searchable and gives you the ability to find the disposal records of a single asset by simply typing in the barcode label. We make sure every device is accounted for, tracked, and all details are reported. It’s our commitment to providing 100% FDA compliant product destruction.

Fast & Seemless Processing

We know every medical device manufacturers needs are different when a recall or removal is necessary. Our team will work with you to provide a seamless and fast transition to our facility for processing.

Ship your products directly to us from your manufacturing facility. We log all incoming shipments that come into our secure warehouse.
We can pick up your devices from your warehouse or from healthcare facilities. Using our GPS tracked vehicles, you’ll get full chain-of-custody reporting.
Your end users can return their devices to us. We scan every serial number and quarantine any unknown devices or parts.