Reported Nov 16, 2016 · Terminated
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1,…
Baylis Medical Corp. *
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baylis Medical Corp * · 5959 TransCanada Highway · Montreal · N/A
Is this the product you have?
- NRG Transseptal Needle and NRG RF Transseptal Kit
- Model/Catalogue NumbersNRG-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
- Lot codes and dates
- Lot numbers
232 of 232 codes
NGFA240216NGFC041115NGFH211215NGFA071015NGFA151215NGFB021115NGFB090216NGFB090616NGFB101115NGFB220216NGFB231115NGFB281015NGFC110416NGFC120116NGFC180416NGFC211015NGFC250116NGFC301115NGFD030616NGFD080716NGFD091215NGFD171115NGFD250416NGFE020216NGFE090516NGFE200116NGFE240516NGFF180716NGFF211215NGFH210316NGFH290416NGFI120216NGFI270616NGFA211015NGFB111115NGFB120116NGFB140316NGFB200616NGFB271015NGFC090516NGFC161115NGFC211215NGFD021115NGFD081215NGFD160516NGFE050116NGFE090216NGFE120216NGFE290416NGFF220216NGFF231115NGFF250416NGFF270616NGFF301115NGFG240316NGFG260116NGFG300516NGFH240516NGFH290216NGFI020216
- Lot numbers
- Amount recalled
- 28,093 units
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.
This product could cause temporary or reversible health problems — stop using it.
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