Recall Z-0393-2017
Baylis Medical Corp * · initiated October 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0393-2017
- Initiated
- October 11, 2016
- Posted by FDA
- November 10, 2016
- Terminated
- July 10, 2017
- Product code
- DXF – Catheter, Septostomy
- Quantity
- 28,093 units
- Distribution
- Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
- Recalling firm
- Baylis Medical Corp *, Montreal