Recalls / —
—#152601
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.
- FDA product code
- BTQ — Airway, Nasopharyngeal
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lot/Batch Numbers 16A14 and 16A14
Why it was recalled
Labeling error
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
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.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2017-01-13
- Terminated
- 2025-02-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152601. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.