B Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a sterile barrier packaging defect that is theoretical in nature (potential compromised sterility); the source text does not indicate that any adverse health consequences have been documented.
Plain-English summary
Galt Medical Corporation is recalling approximately 1,400 B Braun Interventional Coaxial Dilator Micro-Introducer Kits (reference numbers KIT-018-47, KIT-019-67, KIT-018-41, and KIT-019-37) due to a potential open seal in the sterile barrier packaging. These kits are medical devices intended to introduce guidewires or catheters into the vascular system following a needle stick procedure.
The affected kits have been distributed nationwide in the U.S. states of Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. Specific lot numbers are identified: S25052261, P25052052, S25064124, and P25115062.
A potential open seal in the sterile barrier packaging compromises the sterile condition of the device. Consumers or healthcare facilities that have received these kits should stop use and contact Galt Medical Corporation for further instructions. Healthcare providers should review whether any of the affected kits were used in patient procedures.
The recalled product
- Product
- B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
- Manufacturer
- Galt Medical Corporation
- Hazard
- sterile-barrier-failure
- packaging-defect
Distribution
Distributed nationwide across the United States.
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