Fresenius Medical Care has announced the immediate recall of two sets of its 4008 bloodlines, AV-Set B-R F00001124 and AV-Set SRB-R F00000257, containing a total of 25 batches. The tubes could rupture leading to potentially deadly blood leakage and/or air air entry to a patient’s bloodstream, that the dialysis machine would not detect and alarm.
The FDA has announced an urgent Class I recall of all lots of the Fresenius Kabi Volumat MC Agilia Infusion Pump System (model Z021135, Software Versions 1.7 and 1.9a) and Vigilant Drug Library (Z073476, Software Versions 1.0 and 1.1) because of inappropriate alarms that have potential to create serious injury or death. For details see https://kcercoalition.com/alerts or https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-kabi-recalls-volumat-mc-agilia-infusion-pump-and-vigilant-agilia-drug-library-due-low.
The FDA has announced the Class II recall of over two million Covidien Mahurkar and Argyle acute hemodialysis catheters because of inaccurate instructions. For lot numbers see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172734.
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.