Introcan Safety Catheter Recalled for Potential Leakage at Hub
B. Braun is recalling 94,000 Introcan Safety FEP 14G catheters due to potential leakage at the catheter hub. Affected units were distributed in the US and Canada.
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: This is an FDA Class II recall of a risk-of-harm medical device (catheter with leakage potential) where no illnesses, injuries, or deaths have been reported. Per the rubric, theoretical hazards without reported harm are scored at most 3 (High).
Plain-English summary
B. Braun Medical Inc is recalling the Introcan Safety FEP 14G catheter (Product Code 4251890-02), a passive anti-needle device used for venous and arterial access. The recall affects approximately 94,000 units.
The reason for the recall is a potential for leakage at the catheter hub.
The recalled product was distributed domestically in Arizona, California, Florida, Georgia, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, and Washington, as well as to Canada. The affected lot numbers are 22D04G8241, 22D07G8241, 22D07G8242, 22E30G8241, and 22E30G8242, with expiration dates of April 1, 2027 or May 1, 2027.
Consumers and healthcare facilities in possession of the recalled product should discontinue use and contact B. Braun Medical Inc for further instructions.
The recalled product
- Product
- Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
- Manufacturer
- B Braun Medical Inc
- Hazard
- Affected units
- 94,000
Distribution
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