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.

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.

A recall notification, marked URGENT Voluntary Medical Device Recall was sent by Baylis Medical Company via overnight courier to all customers affected by the recall with an Acknowledgement Form. Customers were asked to examine their inventories, quarantine any affected lots, and complete the attached Acknowledgement Form. The form should be returned to Baylis Medical Company via the instructions provided. Upon receipt, the firm will contact customers with information on how to return affected product. Questions regarding the letter can be directed to the Customer Service Department at 1-800-276-4416.