Z-1506-2014Class II

Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a...

Name: Z-1506-2014 Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a...
Creator: Teleflex Medical
Published: 2014-03-04
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-04 / Terminated / root cause: sterility

FDA source

Teleflex Medical began a recall of Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of... on 2014-03-04. FDA classified it as Class II and gives the reason as "Sterility of the product cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1506-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-04
Posted: 2014-04-24
Terminated: 2016-01-28
Recalling firm: Teleflex Medical
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Sterility of the product cannot be guaranteed.
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 117,801 ea.
Distribution: 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.
Product codes and lots: Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code KNT

K981203Class IIRusch Blakemore 3 Lumen, SterileRusch Intl. / cleared 1998-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)