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U.S. Department of Health and Human Services

Class 2 Device Recall Electrical surgical clipper and base

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  Class 2 Device Recall Electrical surgical clipper and base see related information
Date Initiated by Firm September 06, 2019
Create Date September 26, 2019
Recall Status1 Open3, Classified
Recall Number Z-2756-2019
Recall Event ID 83740
Product Classification Razor, surgical - Product Code LWK
Product MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800

Product Usage:
Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.
Code Information 14G1
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Benjamin Gora
866-359-1704
Manufacturer Reason
for Recall		 The 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.
FDA Determined
Cause 2		 Process control
Action Medline Industries initiated the recall on 09/06/2019 by letter. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Immediately check your stock for the affected item number and lot number listed on the destruction form. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form. For questions contact 866-359-1704.
Quantity in Commerce 500 units
Distribution US Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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