Date Initiated by Firm |
December 16, 2016 |
Date Posted |
March 03, 2017 |
Recall Status1 |
Terminated 3 on April 17, 2017 |
Recall Number |
Z-1399-2017 |
Recall Event ID |
76299 |
510(K)Number |
K984528 K092886
|
Product Classification |
Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
|
Product |
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries |
Code Information |
Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F |
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 |
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064. |
Quantity in Commerce |
1,060 units |
Distribution |
Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee. |
Total Product Life Cycle |
TPLC Device Report
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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 = CBI and Original Applicant = PARKER MEDICAL ASSOC. 510(K)s with Product Code = CBI and Original Applicant = WELL LEAD INSTRUMENTS
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