Device Recall Medline Industries Inc. 의 리콜

Recall

71720

Class 2

Z-2433-2015

2015-07-08

2015-08-20

Terminated

United States

2017-11-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138826

Charging base of surgical clippers overheats and smokes.

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.