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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Extended PTFE Coated Blade electrosurgical electrodes

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 Class 2 Recall
Medline Extended PTFE Coated Blade electrosurgical electrodes
see related information
Date Posted October 21, 2009
Recall Status1 Terminated on May 12, 2010
Recall Number Z-0069-2010
Recall Event ID 53498
Premarket Notification
510(K) Number
K962935 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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, Florida 33777-1415
Consumer Instructions Contact the recalling firm for information
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = UNIMED SURGICAL PRODUCTS, INC.
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