| |
Class 2 Device Recall Rusch, Latex Free Robertazzi Airway |
 |
| Date Initiated by Firm |
January 13, 2017 |
| Create Date |
March 21, 2017 |
| Recall Status1 |
Completed |
| Recall Number |
Z-1519-2017 |
| Recall Event ID |
76263 |
| Product Classification |
Airway, nasopharyngeal - Product Code BTQ
|
| Product |
Teleflex 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 Contact |
Elizabeth Lutton
919-544-8000
|
Manufacturer Reason
for Recall |
Labeling error
|
FDA Determined
Cause 2 |
Unknown/Undetermined by firm |
| Action |
Consignees 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 Commerce |
7,600 eaches |
| Distribution |
Worldwide 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 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.
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