Class 2 Device Recall Exodus Standard Loop Multipurpose Drainage Catheter

• Date Initiated by Firm: May 24, 2010
• Date Posted: October 07, 2010
• Recall Status: Terminated on October 07, 2010
• Recall Number: Z-0015-2011
• Recall Event ID: 56219
• 510(K)Number: K093392
• Product Classification: catheter, biliary, diagnostic - Product Code FGE
• Product: Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. ; Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
• Code Information: Lot 1PD0050401
• Recalling Firm/ Manufacturer: Navilyst Medical, Inc; 10 Glens Falls Technical Park; Glens Falls NY 12801
• For Additional Information Contact: Michael Duerr; 518-742-4571
• Manufacturer Reason for Recall: One box containing five catheters did not complete the sterilization process prior to distribution.
• FDA Determined Cause: Employee error
• Action: On/about 5/24/10, NMI telephoned the consignee. The recall notification package was sent by NMI to the sole consignee on 6/11/10, followed by a telephone call by NMI Quality staff. On 6/15/10, the recall notification package was sent via FedEx to the sole consignee. Subsequently the consignee was provided a return goods authorization (RGA) number for return to NMI. The letter described the product, problem and action to be taken by the consignee/customer. The consignee/customer was instructed to immediately discontinue use of and segregate recalled product; remove the affected lot from their inventory; complete and return the Reply Verification Tracking Form via fax to the QA Manager; Navilyst Medical, Inc., at 1-518-742-4414; to please call the Navilyst Medical Customer Service at 1-800-833-9973 between 8:30 a.m. and 7:00 p.m. (Eastern Standard Time) to obtain a Return Authorization (RGA) Number, and package/ship the recalled product to Navilyst Medical, Inc, Distribution Center, Attn: QA Returns, 10 Glens Falls Technical Park, Glens Falls, NY 12801. If you have any questions, call Navilyst Medical Customer Service at 1-800-833-9973. Subsequent to the initial notification letter, NMI identified that a typo was made to the lot number on the letter. NMI telephoned the consignee and sent a revised letter via fax on 6/25/10 indicating the correct lot number.
• Quantity in Commerce: 1 box unit (contains 5 catheters)
• Distribution: Nationwide distribution: Ohio only
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FGE and Original Applicant = NAVILYST MEDICAL, INC.