IV Catheter Valve Housing May Detach and Cause Leakage
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
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 medical device with a risk-of-harm defect (valve housing detachment causing leakage in an IV catheter), but no reported injuries or adverse events documented in the source. Classified as High due to the critical nature of IV catheters in patient care.
Plain-English summary
B. Braun Medical Inc. is recalling Introcan Safety 3 Closed IV Catheter (22 Ga. x 1 inch, PUR, Winged). This is a passive safety IV catheter used in healthcare settings for intravenous access.
The recall is due to an increased risk of valve housing detachment, which can cause fluid leakage. This defect could result in loss of intravenous access or fluid administration complications.
Approximately 28,200 units have been distributed domestically in California, Florida, Georgia, Illinois, Indiana, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas, Virginia, and Washington. Additional units were distributed internationally to Canada. The affected lot is 24F09G8952 (Model No. 4251128-02).
Customers and healthcare facilities should immediately stop using the recalled catheters. The manufacturer and relevant healthcare authorities have been notified of this recall. For more information, contact B. Braun Medical Inc. or the FDA.
The recalled product
- Product
- Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 28,200
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 (3)
- Model No 4251128-02
- UDI-DI 04046964014017
- Lot 24F09G8952.
Distribution
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