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U.S. Department of Health and Human Services

Class 2 Device Recall Parker Left Double Lumen Endobronchial Tube with Parker FlexTip

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  Class 2 Device Recall Parker Left Double Lumen Endobronchial Tube with Parker FlexTip see related information
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
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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