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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution

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  Class 2 Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution see related information
Date Initiated by Firm August 31, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on April 12, 2016
Recall Number Z-0240-2016
Recall Event ID 72098
Product Classification General surgery tray (kit) - Product Code LRO
Product DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE:

TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03;
KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01;
TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09;
PACEMAKER PACK, REF 89-8381.01;
Code Information REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071 
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact William G. Pittman
865-362-2901
Manufacturer Reason
for Recall		 Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
FDA Determined
Cause 2		 Other
Action DeRoyal initiated their recall on 08/31/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. Hospitals were provided with labels to affix to the kits with direction to discard the recalled component and notice of destruction forms to be completed and returned.
Quantity in Commerce 355 units
Distribution SC, FL, OH, NJ, OK, MN, AR
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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