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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Industries Inc.

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  Class 2 Device Recall Medline Industries Inc. see related information
Date Initiated by Firm July 08, 2015
Date Posted August 20, 2015
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-2433-2015
Recall Event ID 71720
Product Classification Razor, surgical - Product Code LWK
Product Medline Electrical Clipper with Charging base

The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
Code Information Product item number: DYND70800 with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4485
For Additional Information Contact Terence A. Alwin
847-643-4086
Manufacturer Reason
for Recall		 Charging base of surgical clippers overheats and smokes.
FDA Determined
Cause 2		 Process control
Action Medline Industries sent a " Urgent Remedial Action Destruction Form " letter via first class dated July 9, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. ***URGENT RECALL IMMEDIATE ACTION REQUIRED SURGICAL CLIPPER CHARGER BASE DYND70800 *** Medline Industries, Inc. is recalling specific lots of the Medline Surgical Clippers Charger Base (base only). This recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction. These lots were distributed October 2013 through March 2015. After further investigation we have determined the root cause to be a defective circuit board. This defect has since been corrected. REQUIRED ACTION: 1. Immediately check your stock for item number DYND70800 and the affected lots listed on the destruction form, dispose of the affected charger base only (do not dispose of the clipper). 2. Please return the completed enclosed destruction form listing the quantity of affected charger base(s) you destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form we will send you replacement charger base(s). 3. If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704. As the distributor of this product, we sincerely regret the inconvenience. We, like you, place the health and safety of your patients first and foremost. This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Quantity in Commerce 7062 units (U.S.); 540 units Foreign
Distribution Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : United Arab Emirates, Barbados, Bahamas, Chile, Costa Rica, Italy, Lebanon, and Singapore.
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.
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