FDA Device recall Z-1506-2014
Sengstaken Tube and Sengstaken-Blakemore Tube
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of Sengstaken Tube and Sengstaken-Blakemore Tube by Teleflex Medical, citing sterility of the product cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1506-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-04 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1506-2014%22
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