IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk
B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.
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: This is an FDA Class II medical device recall for a risk-of-harm product (IV access device) with potential for serious complications including bloodstream infections and life-threatening conditions such as air embolization. No illnesses or injuries are documented in the source text; the score reflects the inherent risk profile without confirmed reported harm.
Plain-English summary
B. Braun Medical, Inc. is recalling Extension Sets (EXT SET W/CARESITE, 6IN., Product Code 470169) used for IV fluid and blood administration. The devices have a high probability of failure at the bonded joint, which may result in leakage or detachment during use.
When extension sets fail, patients and healthcare workers face risks including delayed therapy, increased risk of bloodstream infections, and potential exposure to hazardous medications. Depending on the type and extent of the leak, life-threatening complications such as air embolization or hypovolemia are possible.
Approximately 354,200 units were distributed in the United States, with an additional 1,800 units distributed to Canada and Saudi Arabia. The affected lot numbers and expiration dates are identified in the FDA recall notice.
If you are using affected extension sets, contact B. Braun Medical or your healthcare facility immediately. Do not continue using the recalled devices.
The recalled product
- Product
- Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- device-failure
- leakage
- bloodstream-infection
- air-embolization
- hypovolemia
- medication-exposure
Distribution
Distributed nationwide across the United States.
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