B. Braun Introcan IV Safety Catheters Recalled for Lack of FDA Approval
Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products do not have FDA approval for sale in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any specific injuries, illnesses, or deaths, and the primary issue is regulatory non-approval rather than a confirmed physical defect causing harm.
Plain-English summary
Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters, sterile. The recall involves 1,781 cases of the product. The device is a single-use item used to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
The recall was initiated because the recalled products do not have FDA approval for sale in the United States. The affected products were distributed nationwide, including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, and WA.
The specific lot numbers involved are all item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, and 4254546-01. Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
- Manufacturer
- Braxton Medical Corporation
- Category
- Medical Device — IV Catheters
- Hazard
- Affected units
- 1,781
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 (16)
- All lot numbers under item codes ending in -01: 4251601-01
- 4251628-01
- 4251652-01
- 4251687-01
- 4251890-01
- 4252500-01
- 4252519-01
- 4252527-01
- 4252535-01
- 4252543-01
- 4252560-01
- 4252586-01
- 4252594-01
- 4253523-01
- 4253540-01
- 4254546-01.
Distribution
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