Safety Alert for CENTRAL VENOUS CATETER FOR HEMODIALISE LOGICATH - DOUBLE LUMEN - Registration 80228990022 and CENTRAL VENOUS CATETER FOR HEMODIALISE LOGICATH - TRIPLE LUMEN - Registration 80228990019 - CODES AND LOTS as listed in the appendix. "http://migre.me/5vfyz"

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Smiths Medical has identified the root cause for this problem as changing the resin used in the production of the clamp, which seems to allow excessive clamp flexibility. This problem has already been solved in manufacturing. Although not all the devices in the attached list will exhibit this problem, the company is acting proactively by applying this security corrective action to all listed devices. In addition to this recall action, Smiths Medical will add the following warning in the Instructions for Use of these products: "Warning: Do not use extension line clamp as a replacement for the closure cap. Clamp use is for temporary closure only of extension lines during connection or disconnection from one system to another from the catheter Patients must be kept under observation at all times when the extension tube clamp is in use and until a closure cap is attached. Anvisa is accompanying this action. #### 09/09/2011 - The company sends complements of lots involved in the Collection #### 14/10/2011 - Update: the Company sends a partial report, where it states that 45% of customers returned the form with information from the stock and that the collected products are being segregated for destruction. #### 11/16/2011 - Update: the Company forwards a partial report, where it states that 85% of customers returned the form with information from the inventory and that the collected products are being segregated for destruction. #### 16/07/2012 - UPDATE - The company forwards the report of completion of the field action, where it declares the collection of 5315 units and it awaits the destruction in a segregated place at the company #### CLOSURE - 02/21/2013 - The company forwards the file 0144339 / 13-9, where it presents Certificate of Destruction of the products collected.