Recall Z-0393-2017 ยท DXF Catheter, Septostomy
Baylis Medical Corp *
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.
| Date | Nov 10, 2016 (initiated Oct 11, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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 1-8 |
| Quantity | 28,093 units |
| Distribution | Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073326 | NRG TRANSSEPTAL NEEDLE Baylis Medical Co., Inc., May 28, 2008 |