Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues
Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.
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, but the source text identifies the issue as a documentation failure regarding shelf life without reporting any illnesses, injuries, or specific contamination hazards. This aligns with the rubric for moderate severity involving labeling/documentation issues or low-risk theoretical hazards.
Plain-English summary
Greatbatch Medical is recalling the Bard Access Division Coaxial Micro-Introducer Set. The recall was initiated because the company identified that the documentation does not support the five-year shelf life of the product.
The affected product is a medical device used to introduce a guidewire or catheter into the vascular system. The set contains a 21 gauge disposable introducer needle, a 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The recall covers 6,642 sets (66,420 devices) distributed nationwide in the state of Utah.
This is an FDA Class II recall. No specific adverse health consequences or injuries are reported in the source text. Consumers and healthcare facilities should check their inventory for the specific part numbers and lot codes listed in the official recall notice and contact Greatbatch Medical for instructions on returning or disposing of the affected units.
The recalled product
- Product
- Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit
- Manufacturer
- Greatbatch Medical
- Category
- Medical Device — Vascular Access
Distribution
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