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U.S. Department of Health and Human Services

Class 2 Device Recall Parker TrachVac Endotracheal Tubes

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  Class 2 Device Recall Parker TrachVac Endotracheal Tubes see related information
Date Initiated by Firm June 02, 2016
Date Posted July 19, 2016
Recall Status1 Terminated 3 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 2
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 and Original Applicant = WELL LEAD MEDICAL CO. LTD
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