Date Initiated by Firm | November 28, 2022 |
Date Posted | January 05, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0906-2023 |
Recall Event ID |
91287 |
Product Classification |
General surgery tray - Product Code LRO
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Product | DeRoyal Tonsillectomy Tray, REF 89-10698.01 |
Code Information |
GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
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For Additional Information Contact | Theresa Marsee 865-362-6465 |
Manufacturer Reason for Recall | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | DeRoyal issued an URGENT! DEROYAL RECALL NOTICE on 11/28/2022 to the distributor by email and to the end used by overnight USPS. The notice explained the problem and requested the following actions be taken:
1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product.
2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than December 15, 2022.
3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.
4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY.
5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer list and we will contact them. |
Quantity in Commerce | 320 units |
Distribution | Distribution in US states of VA, and SC. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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