FDAFDA · Food and drugs·Recall number Z-1506-2014
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.
Published April 30, 2014 · Recall initiated: March 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of the product cannot be guaranteed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- 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.
- Lot
- Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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