B Braun Coaxial Dilator Kits Recalled for Potential Sterile Barrier Seal Failure
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to potential open seals in the sterile barrier packaging, which may compromise device sterility.
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 a risk-of-harm product (sterile barrier failure on an invasive medical device) where injury has not yet been reported. A compromised sterile seal on a vascular introducer kit creates potential for contamination and infection, though no adverse events have been documented in the source material. The Class II designation supports a score between 2 and 3.
Plain-English summary
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits (REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37) due to a potential open seal in the sterile barrier packaging. These kits are designed to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
The compromised sterile barrier seal could allow contamination to reach the device, potentially affecting its safety for use in vascular interventional procedures. A total of 1,400 dilators have been identified in this recall.
Distribution includes U.S. states (AL, FL, GA, IL, MA, OH, PA, UT) and international distribution to Canada, Ireland, Israel, Korea, Qatar, and United Kingdom. Affected units are identifiable by specific lot numbers associated with each kit reference number.
Healthcare facilities and patients should verify their kits against the recalled lot numbers and contact Galt Medical Corporation with questions.
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-compromise
- contamination-risk
- infection-risk
Distribution
Distributed nationwide across the United States.
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