Baylis Medical Recalls NRG Transseptal Needles Due to Packaging Defect
Baylis Medical Corp is voluntarily recalling NRG Transseptal Needles and RF Kits because the Tyvek packaging pouches may have integrity defects.
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 2/5 (Moderate).
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 and is a voluntary precautionary measure regarding a packaging integrity defect, with no reported injuries or illnesses.
Plain-English summary
Baylis Medical Corp is voluntarily recalling specific lots of the NRG Transseptal Needle and NRG RF Transseptal Kit. The recall is due to the possibility of an integrity defect in the Tyvek pouch used to package the NRG Transseptal Needle.
The affected products include various model and catalogue numbers, such as NRG-56-32-C0, NRG-71-C0, and NRG-98-C0. A total of 28,093 units are involved in this recall. The products were distributed worldwide, including in the US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
The NRG Transseptal Needle is used to create an atrial septal defect in the heart. Users should check their inventory against the list of affected lot numbers provided in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor.
The recalled product
- Product
- NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray…
- Manufacturer
- Baylis Medical Corp *
- Hazard
- Affected units
- 28,093
Distribution
Distribution scope not specified by the agency.
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