ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
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: FDA Class II recall with theoretical hazards including potential for life-threatening complications such as air embolization or hypovolemia, but no reported illnesses or injuries.
Plain-English summary
B. Braun Medical, Inc. is recalling the ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515. Approximately 354,200 units were distributed throughout the United States, and 1,800 units were distributed to Canada and Saudi Arabia.
The extension sets have a high probability of failure at the bonded joint during use. This failure could result in leakage or detachment of the device from the intravenous line.
Device failure may delay necessary therapy and increase the risk of bloodstream infections in patients. Both patients and healthcare workers may be exposed to hazardous medications. Depending on the nature of the leak and the type of infusion, life-threatening situations could occur, including air embolization (air entering the bloodstream) or hypovolemia (significant loss of blood volume).
The recalled product
- Product
- ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
- Manufacturer
- B. Braun Medical, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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