The FDA has announced the Class II recall of Arrow International Hemodialysis Catheterization Kits because of danger of needlestick injury. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_154713 .
The FDA has warned that the diabetes drug Canagliflozin (Invokana, Invokamet) is associated with increased risk of amputation. For details see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm .
The following message is from CMS.
If you are the victim of ransomware or have cyber threat indicators to share
If you or your organization is the victim of a ransomware attack, please contact law enforcement immediately.
- Contact your FBI Field Office Cyber Task Force, at https://www.fbi.gov/contact-us/field-offices/field-offices , immediately to report a ransomware event and request assistance. These professionals work with state and local law enforcement and other federal and international partners to pursue cyber criminals globally and to assist victims of cyber-crime.
- Report cyber incidents to both of the following:
- For further analysis and healthcare-specific indicator sharing, please also share these indicators with the HHS Healthcare Cybersecurity and Communications Integration Center (HCCIC) via email to HCCIC_RM@hhs.gov
The FDA has announced a warning that rare but serious allergic reactions have been reported with widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. The FDA has asked manufacturers to add a new warning label. For full details, including FDA recommendations for continuing use, see http://www.fda.gov/Drugs/DrugSafety/ucm530975.htm .
The FDA has issued a warning about diabetes medications containing Pioglitazone, including Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni, because of elevated risk of bladder cancer. For details see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm .
The FDA has announced these Class II recalls of Baxter products:
- APD Set with Cassette 3-Prong Peritoneal Dialysis Set for use with Baxter HomeChoice PD systems, because of reports of leaks. For details see http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_151903 .
- Phoenix Hemodialysis delivery system Maintenance Kit PH1, Code 6997266, lot numbers 1607250, 160824D, 161005D, and 161026D, because of incorrect component packaging. Details at http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_152438 .
- Phoenix Hemodialysis delivery system Maintenance Kit PH2, Code 6997274, lot numbers 160718E, 160720E, and 160825E, because of incorrect component packaging. Details at http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_152439 .
The FDA has announced a Class 2 recall of all serial numbers of the Fresenius HD Systems 2008T, 2008K, 2008K2, and 2008K@Home Series because the machines do not execute the indicated UF rate when the UF rate, goal, or time is adjusted using the up/down arrow keys and then subsequently canceled with the ESC key. Until Fresenius issues and installs a software upgrade, all users are advised to use the numeric keys to adjust values, then use the CONFIRM key to save the values. For full details see:
- 2008T – http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_152017
- 2008K – http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152019
- 2008K2 – http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_152020
- 2008K@Home – http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_152021