Recall Z-1506-2014 ยท KNT Tubes, Gastrointestinal (And Accessories)
Teleflex Medical
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.
| Date | Apr 24, 2014 (initiated Mar 4, 2014) |
| Status | Terminated |
| Reason | Sterility of the product cannot be guaranteed. |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981203 | RUSCH BLAKEMORE 3 LUMEN, STERILE Rusch Intl., Jun 5, 1998 |