The FDA has issued a warning that pre-owned or unauthorized test strips for insulin, warfarin, and other uses may produce inaccurate results with possible serious consequences. For details see https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635478.htm.
The FDA has announced a recall of Medcomp 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171580.
The FDA has announced a class II recall of lot Y281477, Expiry 02/2020, of Baxter Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only, Product Code 5B9766, NDC 0941-0424-52 due to leaks. For full details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170205.
The FDA has announced a Class II recall of 4 lots of Fresenius Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E, Lot Numbers 18HU06016, 18HU06017, 18HU06018, and 18HU06019, because of blood leaks. For details see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=169039.
CDC has urged everyone to avoid all Romaine Lettuce until further notice, as it is the leading suspect in a multi-state outbreak of Shiga toxin producing Escherichia coli O157:H7 (E. coli O157:H7) infections, and a specific source has not been identified. CDC recommends that drawers and shelves that held Romaine be sanitized. They also recommend that antibiotics NOT be used for this type of infection, as the combination can result in kidney failure, and no benefits have been demonstrated. For detailed instructions, see https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html.
The FDA has announced recalls of 120 Fresenius 2008T Hemodialysis Systems with BlueStar Premium Upgrade kits:
- 2008T Hemodialysis System WITH CDX, Part #190713, Applicable only with 2008T BlueStar Premium Upgrade Kit (80 units); for details see
- 2008T Hemodialysis System w/BIBAG, Part #190766, Applicable only with 2008T BlueStar Premium Upgrade Kit (40 units); for details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=166791.
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
CDC has issued a HAN Health Alert advising that travelers returning from northern Israel have been coming back with leptospirosis, a bacterial disease that among other results can cause kidney failure. For details see https://content.govdelivery.com/accounts/USCDC/bulletins/20ba899.