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.
What this means for you
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.
- Hazard
- device-failure
- infection-risk
- air-embolism
- hypovolemia
Distribution
Distributed nationwide across the United States.
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