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U.S. Department of Health and Human Services

Class 2 Device Recall Mediline Industries, Inc.

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  Class 2 Device Recall Mediline Industries, Inc. see related information
Date Initiated by Firm June 16, 2010
Date Posted August 28, 2012
Recall Status1 Terminated 3 on August 30, 2012
Recall Number Z-2288-2012
Recall Event ID 61982
510(K)Number K962935  K944265  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***"


Part # ES0016AM -- Lot #: 062408-08, 062509-01.

Product Usage: Intended for cutting and coagulation of soft tissue.
Code Information Lot #: 062408-08, 062509-01.
Recalling Firm/
Manufacturer		 Unimed Surgical Products, Inc.
10401 Belcher Rd South
Largo FL 33777-1415
For Additional Information Contact
727-546-1900
Manufacturer Reason
for Recall		 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
FDA Determined
Cause 2		 Process control
Action Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.
Quantity in Commerce 1440 each
Distribution US Nationwide Distribution - including the state of IL.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = UNIMED SURGICAL PRODUCTS, INC.
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