FDA defines a Class I recall as a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recalls are as follows (click each link to view the FDA report on the specific recall):
1. Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters
2. Terumo Coronary Ostia Cannula 10, 12, 14 Fr
3. Maquet Datascope Corp. Intra-Aortic Balloon Pumps
4. Churchill Medical (Vygon) Skin Prep Wipes
Related Articles on Recalls:
American Regent Initiates Single Lot Recall of Methyldopate HCL Injection
Churchill Medical Systems Recalls Hospital-Use Convenience Kits
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