Baylis Medical Corp * recalls NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-…

Recall date

October 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0393-2017

FDA classification

Class II

Brand / firm

Baylis Medical Corp *

Sold / distributed

Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.

Why it was recalled

The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.