—#138826

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.

FDA product code: LWK — Razor, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product item number: DYND70800 with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.

Why it was recalled

Charging base of surgical clippers overheats and smokes.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4485

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-07-08
Posted by FDA: 2015-08-20
Terminated: 2017-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.