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Teleflex Medical recalls Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal t
Recalled April 30, 2014 · FDA recall Z-1506-2014 · Teleflex Medical
Hazard
Sterility of the product cannot be guaranteed. · FDA Class II
Units
117,801 ea.
Sold at
Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the countries of Algeria, Andorra, Armenia, Argentina, Austria, Australia, Azerbaijan, Belarus, Bermuda, Bahamas, Boliva, Brazil, Canada, Chile, China, Costa Rica, Cyprus, Czechoslovakia, Germany Guatemala, Denmark, Estonia, Egypt, Finland, France, Great Britain, Georgia, Guadeloupe, Greece, Guyana, Curacao, Hungary, Israel, India, Italy, Jordan, Japan, Kuwait, Kazakhstan, Luxembourg, Latvia, Libya, Madagascar, Macedonia, Martinique, Malta, Mauritius, Mexico, Nicaragua, Nigeria, Netherlands, Norway, Oman, Peru, French Polynesia, Poland, Portugal, San Marino, Singapore, Spain, Suriname, San Salvador, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan, Wallis & Futuna Islands, Zambia.
Description
Sterility of the product cannot be guaranteed.
Product
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →