IV extension set recall for potential joint failure and leakage risk
B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.
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 medical device recall with potential for serious patient harm including bloodstream infection and life-threatening complications (air embolization, hypovolemia), but no reported illnesses or injuries documented in the source. Meets rubric criterion for high-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the CARESITE SMALLBORE EXT SET T-PORT 5 IN. (Product Code 470114). This is a valve device intended for aspiration, injection, or gravity/pump infusion of IV fluids and blood. The recall affects 354,200 units distributed in the United States and 1,800 units distributed internationally to Canada and Saudi Arabia.
The extension set has a high probability of potential failure at its bonded joint during use, which could lead to leakage or detachment of the device. Such failures may result in delay of therapy, increased risk of bloodstream infections (BSI), and exposure of both patients and healthcare workers to hazardous medications. In some cases, depending on the nature of the leak and type of infusion, there is potential for life-threatening situations including air embolization or hypovolemia.
Affected lots have expiration dates ranging from December 15, 2023 through November 4, 2024. The FDA has classified this recall as Class II.
The recalled product
- Product
- CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — IV / Infusion
- Hazard
- joint-failure
- leakage
- bloodstream-infection-risk
- air-embolization-risk
Distribution
Distributed nationwide across the United States.
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