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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch, Latex Free Robertazzi Airway

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 Class 2 Device Recall Rusch, Latex Free Robertazzi Airwaysee related information
Date Initiated by FirmJanuary 13, 2017
Create DateMarch 21, 2017
Recall Status1 Terminated 3 on February 10, 2025
Recall NumberZ-1519-2017
Recall Event ID 76263
Product Classification Airway, nasopharyngeal - Product Code BTQ
ProductTeleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.
Code Information Lot/Batch Numbers 16A14 and 16A14
Recalling Firm/
Manufacturer
Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactElizabeth Lutton
919-544-8000
Manufacturer Reason
for Recall
Labeling error
FDA Determined
Cause 2
Unknown/Undetermined by firm
ActionConsignees were notified of the recall by letter on 1/13/2017. The letter requested that they immediately discontinue use and quarantine the recalled product. Distributors were requested to conduct a sub-recall. The letter included a reply form which was to be returned to Teleflex.
Quantity in Commerce7,600 eaches
DistributionWorldwide Distribution - US Nationwide in the state of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and the countries of Canada and Mexico.
Total Product Life CycleTPLC 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.
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