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U.S. Department of Health and Human Services

Class 1 Device Recall GeoMed

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 Class 1 Device Recall GeoMedsee related information
Date Initiated by FirmFebruary 13, 2024
Date PostedMarch 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1382-2024
Recall Event ID 94129
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Code Information a) 53-1831 ORTHO TOTAL JOINT TRACECART, GTIN 0749756598088, Lot Numbers: 57587017 exp 2/1/2024, 57760377 exp 2/1/2024, 58185167 exp 5/1/2024, 58628933 exp 6/1/2024, 58834059 exp 9/1/2024, 58864266 exp 7/1/2024, 59223364 exp 7/1/2024, 59355050 exp 2/1/2025, 59548003 exp 5/1/2025; b) 53-1836 GENERAL SURGERY TRACECART, GTIN 0749756598132, Lot Numbers: 58654875 exp 6/1/2024, 58736096 exp 6/1/2024, 59146688 exp 7/1/2024, 59223356 exp 7/1/2024, 59443367 exp 11/1/2024, 59510136 exp 11/1/2024, 59515455 exp 3/1/2025, 59661866 exp 5/1/2025
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactTheresa Marsee
865-362-6465
Manufacturer Reason
for Recall		DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
FDA Determined
Cause 2		Other
ActionDeRoyal Industries notified their sole consignee via email on 02/13/2024. The notice explained the reason for recall, risk, and requested that the affected product Nurse Assist 16F Urine Meter Foley, be removed from the tracecarts and returned. The consignee was instructed to complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory and return the completed form to DeRoyal via fax to 865- 362-3716 or recalls@deroyal.com. For questions regarding credit for the recall, email at recalls@deroyal.com or call 865-362-4203.
Quantity in Commerce134 tracecarts
DistributionFlorida
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = LRO
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