Date Initiated by Firm | October 01, 2008 |
Date Posted | November 07, 2008 |
Recall Status1 |
Terminated 3 on December 02, 2009 |
Recall Number | Z-0198-2009 |
Recall Event ID |
49553 |
Product Classification |
Custom surgical kit - Product Code KDD
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Product | DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit) |
Code Information |
Lot number 13063705 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
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For Additional Information Contact | Mr. Tracy Edmundson 865-362-2334 |
Manufacturer Reason for Recall | Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance. |
Quantity in Commerce | 30 kits |
Distribution | LA & KY |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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