TELEFLEX LLC recalls Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b.

Recalled February 1, 2023 · FDA recall Z-1011-2023 · TELEFLEX

Hazard

Potential for pilot balloon non-inflation or cuff non-deflation. · FDA Class II

Units

39,690 units

Sold at

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.

Description

Potential for pilot balloon non-inflation or cuff non-deflation.

Product

Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation

Manufacturer(s)

TELEFLEX LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →