Sterilmed—Reprocessed Microline Scissor Tips: Insulation May Be Compromised, Potentially Leading to Electrical Shock or Patient Burns
May 18, 2016 | Risk Management News
In an April 27, 2016, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Sterilmed states that the device insulation of the above scissor tips may be compromised because of an inconsistency in the manufacturing process, potentially causing electrical arcing, which can lead to electrical shock or patient burns. The manufacturer has not confirmed the information provided in the source material.
Problem:Identify, isolate, and discontinue use of any affected product in your inventory. If you have affected product, verify that you have received the April 27, 2016, Urgent Medical Device Recall letter and Business Reply Form from Sterilmed. Regardless of whether you have affected product, complete the Business Reply Form and return it to Sterilmed using the instructions on the form. Return affected product to Stericylce using the supplied prepaid shipping label. Notify all relevant personnel at your facility of the information in the Urgent Medical Device Recall letter, and forward a copy of the letter to any facility to which you have further distributed affected product. Retain a copy of...