Baylis Medical Corp *
Baylis Medical Corp * appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0393-2017, Class II) was initiated on October 11, 2016.
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0393-2017 | Class II | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71- | October 11, 2016 |
| Z-0356-2016 | Class II | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device in | October 28, 2015 |
| Z-1442-2015 | Class II | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use devi | March 30, 2015 |
| Z-0085-2014 | Class I | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage | September 23, 2013 |