Safety Alert for Trade name: Control Tip Microline. Technical name: Laparoscopic instruments. ANVISA registration number: 80312270010. Risk class: I. Model: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331, 3341,3351,3361,3371,3381 , 3401, 3411, 3421, 3431. . Series numbers :. . MODEL 3201 - Lots: 00110853,00112170,00113032,00115835, 00111514. MODEL 3221 - Lots: 00110759, 00112307, 00112786, 00113260, 00116751, 00118024, 00133063, 00113472, 00118164. MODEL 3231 - Lots: 00110481, 00111591, 00112869, 00114060 00112971, 00117191, 00117191, 00132930, 00111234. MODEL 3241 - Lots: 00110976, 00113013, 00116418, 00118336, 00111288. MODEL 3251 - Lots: 00110760, 00111197, 00112828, 00115999, 00116403. MODEL 3261 - Lots: 00111367, 00111743, 00111955, 00112820, 00113462, 00116081, 00116498, 00117981, 00113640. MODEL 3271 - Lots: 00110537, 00111557, 00112749, 00116028, 00117360 .. MODEL 3281 - Batch: 00115602 .. MODEL 3291 - Lots: 00111360, 00111869, 00113145, 00116325, 00117975 , 00113464. MODEL 3301 - Lots: 00110196, 00111583, 00112748, 00115010, 00116724 .. MODEL 3311 - Batch: 00114069. MODEL 3321 - Lots: 00111761, 00116666, 00130302, 00132678 .. MODEL 3331 - Lots: 00111236, 00111510, 00112530 , 00114067, 00116715, 00130161, 00113357, 00117979. MODEL 3341 - Lot s: 00111516, 00114068, 00117747, 00130533, 00130304 .. MODEL 3351 - Lots: 00111121, 00112308, 00112947, 00116052, 00116796, 00117792, 00113358. MODEL 3361 - Batch: 00111237, 00116642, 00129918, 00133056 .. MODEL 3381 - Lots : 00114828; 00130320 .. MODEL 3421 - Lots: 00101955, 00104270 .. MODEL 3431 - Lots: 00106637, 00127466. This product was added to our catalog on Monday 01 December, 2008.

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.

1. If there are products in stock, immediately discontinue use of the product and segregate them in quarantine and request recall. 2. To return the product, complete the recall form and send to the distributor or via email tecnovigilancia@tctecnicacirurgica.com. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the collection form, send it to the distributor or via e-mail to tecnovigilancia@tctecnicacirurgica.com. This will confirm that you have received this collection notice. There are no users / patients affected by this issue. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/13/2017 - Date of notification notice to Anvisa: 08/01/2017 The company that owns the product registration is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "