• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NRG Transseptal Needle and NRG RF Transseptal Kit

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall NRG Transseptal Needle and NRG RF Transseptal Kit see related information
Date Initiated by Firm October 11, 2016
Date Posted November 10, 2016
Recall Status1 Terminated 3 on July 10, 2017
Recall Number Z-0393-2017
Recall Event ID 75474
510(K)Number K073326  
Product Classification Catheter, septostomy - Product Code DXF
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 with two lids, which is individually packaged in a Tyvek/nylon pouch.

Used to create an atrial septal defect in the heart.
Code Information Lot numbers: NGFA240216 NGFC041115 NGFH211215 NGFA071015 NGFA151215 NGFB021115 NGFB090216 NGFB090616 NGFB101115 NGFB220216 NGFB231115 NGFB281015 NGFC110416 NGFC120116 NGFC180416 NGFC211015 NGFC250116 NGFC301115 NGFD030616 NGFD080716 NGFD091215 NGFD171115 NGFD250416 NGFE020216 NGFE090516 NGFE200116 NGFE240516 NGFF180716 NGFF211215 NGFH210316 NGFH290416 NGFI120216 NGFI270616 NGFA211015 NGFB111115 NGFB120116 NGFB140316 NGFB200616 NGFB271015 NGFC090516 NGFC161115 NGFC211215 NGFD021115 NGFD081215 NGFD160516 NGFE050116 NGFE090216 NGFE120216 NGFE290416 NGFF220216 NGFF231115 NGFF250416 NGFF270616 NGFF301115 NGFG240316 NGFG260116 NGFG300516 NGFH240516 NGFH290216 NGFI020216 NGFI210316 NGFD220216 NGFF050116 NGFA250116 NGFA240516 NGFD111115 NGFF180416 NGFH140316 NGFH151215 NGFI090616 NGFA241215 NGFB041115 NGFB070316 NGFC020216 NGFC060116 NGFC080816 NGFC120216 NGFC290416 NGFD110116 NGFD210316 NGFE200616 NGFG151215 NGFI250416 NGFB300415 NGFD040915 NGFG140715 NGFB301115 NGFA020316 NGFA030616 NGFA081215 NGFA120216 NGFA211215 NGFA270616 NGFB110116 NGFC071015 NGFC090616 NGFC240316 NGFC240516 NGFD090516 NGFD260116 NGFE040416 NGFE250416 NGFE300616 NGFF070316 NGFF110416 NGFF140316 NGFG180416 NGFJ290416 NGFA081015 NGFA210316 NGFA210616 NGFA240316 NGFA271015 NGFA301115 NGFA310316 NGFB020216 NGFB020316 NGFB030616 NGFB050516 NGFB080716 NGFB090516 NGFB120816 NGFB161115 NGFB270616 NGFB300616 NGFC151215 NGFC160516 NGFC300516 NGFD120216 NGFE020816 NGFE070316 NGFE190116 NGFF290216 NGFG040416 NGFG050116 NGFG140316 NGFG290416 NGFH110416 NGFH180716 NGFI180416 NGFI290416 NGFB180716 NGFB081215 NGFB171115 NGFB210316 NGFB240516 NGFC151015 NGFF190116 NGFF240316 NGFG090616 NGFI110416 NGFA021115 NGFA050516 NGFA090216 NGFA090516 NGFA160516 NGFA161115 NGFA300616 NGFC030616 NGFC110116 NGFD020816 NGFE180416 NGFF151215 NGFG151015 NGFH040416 NGFH090616 NGFJ240316 NGFJ290216 NGFA071215 NGFA190516 NGFB071015 NGFB200116 NGFB290216 NGFD271015 NGFF020216 NGFH180416 NGFH300516 NGFA101115 NGFB081015 NGFB091215 NGFB240316 NGFC200616 NGFD070316 NGFD090616 NGFD211015 NGFD231115 NGFD240516 NGFE030616 NGFE211215 NGFE270616 NGFF120116 NGFF210316 NGFF260116 NGFG120216 NGFH090216 NGFI220216 NGFJ180416 NGFM250416 NGFA300415 NGFB270815 NGFE140715 NGFJ050815 NGFH260116 NGFB120216 NGFC081015 NGFE111115 NGFE260116 NGFG200616 NGFK290216 NGFA190116 NGFB211015 NGFD090216 NGFE140316 NGFF200616 NGFG250416 NTFA160316 NTFA170316 NTFA290616 NTFH040216 NTFB170316 NTFD040216 NTFA020816 NTFA080616 NTFA210316 NTFB170816 NTFA170816 NTFA200716 NTFB100816 NTFB200716 NTFC040216 NTFC170316 NTFC170816 
Recalling Firm/
Baylis Medical Corp *
5959 TransCanada Highway
Montreal Canada
For Additional Information Contact Customer Service Department
800-276-4416 Ext. 185
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 1-800-276-4416.
Quantity in Commerce 28,093 units
Distribution Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXF and Original Applicant = BAYLIS MEDICAL CO., INC.