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U.S. Department of Health and Human Services

Class 2 Device Recall Deroyal

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  Class 2 Device Recall Deroyal see related information
Date Initiated by Firm May 30, 2023
Date Posted July 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-2088-2023
Recall Event ID 92445
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Custom medical procedure packs labeled as:
a) STANDARD OB PACK ASCENSION WI, REF 89-10640
b) ANGIO PACK, REF 89-10901
c) BASIN, REF 89-1924
d) CYSTO PACK, REF 89-7133
e) TOTAL HIP PACK, REF 89-9134
f) EMERGENCY C-SECTION PACK, REF 89-9478
Code Information a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-632-6465
Manufacturer Reason
for Recall		 The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
FDA Determined
Cause 2		 Process control
Action DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
Quantity in Commerce 328 packs
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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.
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