HIGH
FDA DEVICE
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 ...
Cook
Marker bands
Recall database
Multi-state outbreak of E. coli O157:H7.
Multi-state outbreak of E. coli O157:H7.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
Multi-state outbreak of E. coli O157:H7.
Multi-state outbreak of E. coli O157:H7.






Lack of Assurance of Sterility