Class 2 Device Recall AbbVie PEG Kit 20 FR

• Date Initiated by Firm: November 22, 2016
• Create Date: December 17, 2016
• Recall Status: Terminated on July 09, 2019
• Recall Number: Z-0786-2017
• Recall Event ID: 75794
• 510(K)Number: K142793
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: AbbVie PEG Kit 20 FR
• Code Information: AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336
• FEI Number: 3009751352
• Recalling Firm/ Manufacturer: AbbVie Inc.; 1 N Waukegan Rd; North Chicago IL 60064-1802
• For Additional Information Contact: 847-935-1274
• Manufacturer Reason for Recall: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
• FDA Determined Cause: Device Design
• Action: The firm sent an URGENT: MEDICAL DEVICE FIELD CORRECTION NOTIFICATION AbbVie PEG Kit 20 FR to affected customers describing the reason for the notification. The letter asks affected customers to forward this letter to all Movement Disorder Specialists and physicians (e.g. GIs, IRs, and surgeons) that place PEG- J Tubes within your facility. The letter describes actions to be taken for patients still using the AbbVie PEG 20FR Tube. The letter requests user facilities to continue to monitor the performance of the Tube. The firm states that there is no need to replace the AbbVie PEG 20FR Tube if it is functioning as expected and maintaining a viable connection with the Y-Connector. The letter provides the following instructions when establishing a connection between Abbvie PEG 20FR Tube with the 20FR Y-connector, always refer to AbbVie J Intestinal Tube 9 FR to PEG 15 and 20 FR Instructions for Use for 62918-001. The letter notes the following: 1. Ensure that the set-up process clearly follows the sequence of events as described in the instructions for use and the following clarifications. 2. Ensure that the AbbVie PEG 20FR tube is connected to the corresponding 20 Y- connector (see photograph below which shows the difference between the 15FR and 20FR connection diameter). 3. DO NOT USE ALCOHOL CONTAINING PRODUCTS with the AbbVie PEG 20 FR tube as this may result in damage to the tube. 4. Ensure that the Tube Clamp and Tube Clip on Fixation Plate are both closed. 5. Cut off the proximal cone and Fixation Loop of the AbbVie PEG Tube (15FR or 20FR). Note: Ensure that the cut is perpendicular (90 degree angle) to the tube and not on a diagonal as this ensures proper seating of the tube when engaged into the pin of the Y-connector fitting. 6. Slide the colored Fixation Screw (including the outer ring) over the Abbvie PEG Tube: a. For 15 FR, use the Blue/White screw b. For 20 FR, use the Violet/White screw 7. Grasp near the
• Quantity in Commerce: 541 units
• Distribution: U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
• 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 = KNT