Class 2 Device Recall Parker TrachVac Endotracheal Tubes

• Date Initiated by Firm: June 02, 2016
• Date Posted: July 19, 2016
• Recall Status: Terminated on January 31, 2017
• Recall Number: Z-2243-2016
• Recall Event ID: 74547
• 510(K)Number: K110269
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
• Code Information: Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90 Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)
• Recalling Firm/ Manufacturer: Parker Medical; 5085 Weeping Willow Cir; Highlands Ranch CO 80130-4485
• For Additional Information Contact: Christine Cook; 239-307-6064
• Manufacturer Reason for Recall: Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product.
• Quantity in Commerce: 5,500 units
• Distribution: US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
• 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 = BTR