The FDA has announced a Class II recall of 59 lots of Baxter Revaclear 300 Dialyzer, Product Code 114745L, and 3 lots of Baxter Revaclear 400 Dialyzer, Product Code 114746L, totaling 1.3 million units. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=173325 for the Revaclear 300, and https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=173326 for the Revaclear 400.
The FDA has warned that certain Medtronic MiniMed Insulin Pump models are not protected from hackers, who could alter the insulin settings. Medtronic is replacing the inadequately protected pumps. For recommendations on protecting yourself while awaiting a replacement, a list of models and software versions involved, and more information, see https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication.
The FDA has announced the recall of one lot each of two antibacterials manufactured by Emcure Pharmaceuticals and distributed by Heritage Pharmaceuticals, because of non-sterility:
- Amikacin Sulfate Injection USP 250mg/mL Lot# VEAC025 Expiry October 2019
- Prochlorperazine Edisylate Injection USP 5mg/mL Lot# VPCA172 Expiry April 2020
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.