| Class 2 Device Recall Mediline Industries, Inc. | |
Date Initiated by Firm | June 16, 2010 |
Date Posted | August 28, 2012 |
Recall Status1 |
Terminated 3 on August 30, 2012 |
Recall Number | Z-2290-2012 |
Recall Event ID |
61982 |
510(K)Number | K944265 K962935 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***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 # ESE1651 -- Lot # 03059-03
Product Usage: Intended for cutting and coagulation of soft tissue. |
Code Information |
Lot # 03059-03 |
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 |
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 | 1200 each |
Distribution | US Nationwide Distribution - including the state of IL. |
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
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