DeRoyal Industries Inc DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.

Recommended Action

Per FDA guidance

The firm, DeRoyal, initiated the recall by "URGENT! RECALL NOTICE" letter and email on 06/18/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Using the attached Affected Products Listing, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. Please complete the Notice of Return Form and return the part/lot numbers that you have in inventory to us. You will be given credit or replacement for the returned product, whichever you prefer. 2) Complete the Affected Products Listing spreadsheet, indicating all affected products found in your inventory. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 3) Please return the completed Affected Products Listing spreadsheet and the Notice of Return Form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than July 22, 2019. 4) If you have further distributed these products, your customers must notified of this recall. You may either do this directly or notify us that you have done so, or you may provide us with your customer listing and we will contact them. 5) If you have questions or need assistance with the recall, please email: jmarsh@deroyal.com or call 865-362-4203 or email us at recalls@deroyal.com.

Distribution

As reported by FDA

OK