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Class 2 Device Recall Medline Extended PTFE Coated Blade electrosurgical electrodes |
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Date Initiated by Firm |
August 28, 2009 |
Date Posted |
October 21, 2009 |
Recall Status1 |
Terminated 3 on May 12, 2010 |
Recall Number |
Z-0069-2010 |
Recall Event ID |
53498 |
510(K)Number |
K962935
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand.
Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE. |
Code Information |
Product Order No. ES0014, Lot Number: 042209-03. |
Recalling Firm/ Manufacturer |
Unimed Surgical Products, Inc. 10401 Belcher Rd South Largo FL 33777-1415
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For Additional Information Contact |
727-546-1900
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Manufacturer Reason for Recall |
Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.
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FDA Determined Cause 2 |
Process control |
Action |
Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall.
For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225. |
Quantity in Commerce |
1920 units |
Distribution |
Nationwide Distribution -- MI |
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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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = UNIMED SURGICAL PRODUCTS, INC.
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