Teleflex Recalls Sengstaken Tubes Due to Sterility Concerns
Teleflex Medical is recalling Sengstaken and Sengstaken-Blakemore tubes because the sterility of the product cannot be guaranteed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be guaranteed, posing a risk of harm (infection) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling Sengstaken Tubes and Sengstaken-Blakemore Tubes, identified by product codes 204800, 204802, and 204803. These are gastrointestinal tubes and accessories consisting of flexible or semi-rigid tubing used for instilling fluids, withdrawing fluids, splinting, or suppressing bleeding of the alimentary tract.
The recall was initiated because the sterility of the product cannot be guaranteed. The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous countries across multiple continents.
Healthcare providers and facilities should stop using the affected products and contact Teleflex Medical for further instructions. Consumers are advised to check with their healthcare provider if they have used these products.
The recalled product
- 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…
- Manufacturer
- Teleflex Medical
- Affected units
- 117,801
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots 10251
- 10201
- 10301
- 10401
- 10481
- 10381
- 11041
- 11321
- 12151
- 12231
- 1226
- 11201
- 12311
- 123821
- 12474
- 13151
- 13191
- 13211
- 13261
- 13381
Distribution
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