Using Custom Content for Provider-Specific Product Details

Why Use Customized Content

Does your Recall include specific product information such as UDI, serial numbers or lot numbers? Do you want to notify each location of their affected products using this specific information? Do you want to collect responses for each specific UDI?

Custom Content recalls enable the Supplier to specify specific unique device identifiers related to the products for each of the purchase locations affected by the recall event.  With a Custom Content recall, will be alerted to specific product details in addition to general product information. In addition, the supplier can request that a Provider Actions be answered for each unique product versus a more aggregated response across all products affected.

If you are not already familiar with the Supplier's basic recall creation process, please review this article.

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Enabling Custom Content

As a default Custom Content is not enabled.  In order to enable Custom Content, the Administrator may go to Organizational Settings-> General.  There the Administrator may allow customized content settings using the toggle in the Recall Settings area and clicking Save. Setting the Customized Content toggle to the on position will enable customized content for recalls.   This setting should be turned on if your organization ever sends notifications with the specific product identified foreach provider location.  If you do not always have this detailed information, the recall coordinator is able to de-select custom on an ad-hoc basis if needed.

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Add a Recall Event

To add a new event, click “Add” in the top right corner of your screen.

Step 1: Add Recall Details

Enter all required fields:

• Recall Name
• Recall Type
• Recall Date
• Recall ID
• FDA Classification
• Description
• Risk to Health
• Attach any relevant documents for your providers

It is strongly recommended that you include any documents that would have been sent via mail historically in the “Supporting Documents” section.  You may include pdfs, images, spread sheets and other types of files.  These documents will be visible and downloadable to the providers.

Custom Content Flag - Custom Content recalls are relevant when you wish to associate specific product UDI for a particular provider location. For example, if there are specific serial numbers and you wish to associate those serial numbers specifically with provider locations during the recall process. Custom content recalls have specific requirements for product file uploads.

Once finished click “Next” at the bottom of the screen to continue or “Save and close” to save a draft of your recall.  You may easily edit this information as needed while the recall is in Draft mode.

Step 2: Create Affected Product File

From the Product tab of the recall you just created, click Import Products.

Then click Download Template from the pop up.  You will use this template to load the product information and affected locations.  Review it to determine which product fields are relevant for your recall. Keep in mind there are a few fields that are mandatory, listed below.

Mandatory Fields

For each affected product, include a record in the file with the following information:

• ‍Location ID                This is the unique location identifier for the affected provider location loaded as part of your Master Location File during implementation.   In the case of a Custom Content recall each location will be associated with specific product identifiers, such as serial number, lot number.  There may be duplicate location IDs in the file if the location is affected by more than one item.
• ‍Description               Brief description of the affected product
• ‍Catalog Number       Catalog number of the affected product. May include duplicates.
• ‍Customized Field      Serial number, UDI, Lot number or other fields identifying the specific product where you wish to collect specific information from the Provider.  You may identify one or more fields that contain specific product information associated with a particular location. 5 Custom fields are available if you do not see the particular column header you need.

Step 3: Load Affected Product File

From the Product tab, load file you just created by clicking Choose File or Drag the file.  Note the file must be closed.

From the pop up, choose the column(s) from your file that includes the Customized Field(s) as described in previous section.

Once you have chosen the appropriate field, click Process File

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• Review the Product List and click Save to save the results and continue. Note that your Customized Field will include a drop down displaying specific values listed in your file for that product for every field marked as Custom.

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Review Affected Locations by clicking on Affected Location tab.  Location IDs listed in your file will be separated by Status listed below

• Locations Covered – indicates these locations are verified by provider for receipt of electronic notifications
• Not Covered – indicated location has not been verified by Provider and you should continue to send paper notifications to these locations
• Location Unrecognized – indicates this location does not yet exist in the master location file for your organization.

To Download - Use the download icon on the right of each list to download the information if needed

Step 4 - Add Required Actions

Click on the Actions tab at the top to access the Actions list. There you will see a list of standard Template Actions. You will also see a place to add any new action you wish to include for this recall.

Use the pencil icon to edit any of the existing actions.

Actions marked as Custom Action will require a separate response for each product from the Provider User responding to the recall.

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