—#173848

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: Lot 49888830

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Distribution to: OK

Timeline

Recall initiated: 2019-06-18
Terminated: 2020-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.