Recall Z-1506-2014— Teleflex Medical

Name: FDA recall Z-1506-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-04

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-04, terminated 2016-01-28. It names one FDA 510(k) clearance: K981203. 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.. Reason: Sterility of the product cannot be guaranteed..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-04
Terminated: 2016-01-28
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K981203 — RUSCH BLAKEMORE 3 LUMEN, STERILERusch Intl.·cleared 1998-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Sterility of the product cannot be guaranteed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.