Class I Recall: Fresenius Infusion Pump & Drug Library

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.

Recall: Baxter Revaclear Dialyzers

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.

Warning: Medtronic MiniMed Insulin Pumps

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.

Recall: Antibacterials Amikacin, Prochlorperazine

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

For details see https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heritage-pharmaceuticals-inc-issues-voluntary-nationwide-recall-amikacin-sulfate-injection-usp-1gm4.