Terminated

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.

FDA Recall Z-1506-2014 · Posted 2014-04-24

Recalling FirmTeleflex Medical

Recall StatusTerminated

Product CodeKNT

Date Initiated2014-03-04

Date Terminated2016-01-28

Product Quantity117,801 ea.

Reason for Recall

Sterility of the product cannot be guaranteed.

Firm Action

Letters were issued on 3/4/2014 to consignees asking them to immediately discontinue use and quarantine any products with the recalled catalog numbers. Distributors were also asked to conduct a sub-recall. The recall letters included a Recall Acknowledgment Form which was to be faxed back to Teleflex.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981203RUSCH BLAKEMORE 3 LUMEN, STERILERusch Intl. · 1998-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.