![]() ![]() This record will be updated as the status changes. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed. I-80 SET UP INSTRUCTIONS Careful attention to the instructions and the use of aseptic technique is necessary in order to maintain sterility. Deknatel Product Group 600 Airport Road Fall River, MA 02720 U.S.A. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. should be firmly attached to the Pleur -evac Sahara System. US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.ġ A record in this database is created when a firm initiates a correction or removal action. Return Goods Authorization (RGA) number and provide instructions for the return of To A customer service representative will contact you with a ![]() Indicating whether you do or do not have stock and fax it to 1-85 or email Please complete the enclosed Acknowledgement Form as soon as possible If you have affected stock in inventory, immediately discontinue use andĢ. The affected customer is instructed to take the following actions:ġ. Teleflex is recalling this product due to a lack of assurance of sterility. Manufacturing Lot/Serial No.: 73J2000276. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.Ĭatalog No.: DRAC-32S. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. IPP readings were taken at 10, 15, 20 and 30 cmHO of suction (set on the drain unit) at compression rates of 10, 30, 60, 80. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The hyperbaric performance of a Pleur-Evac A-6000 intercostal drain was assessed with and without this added device by measuring simulated IPP with an electronic pressure monitor connected at the patient end of the PDU. The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). ![]()
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