Recall: Baxter AKI Prismaflex Control Unit

The FDA has announced Class II recalls of Baxter Prismaflex Control Units for AKI Recovery (https://www.baxter.com/healthcare-professionals/critical-care/prismaflex-system-critical-care) with software versions below 7.21 because of communication errors that may interrupt or delay therapy or result in blood loss.  Product Codes and Lot Numbers recalled include:

Recall: BD Trialysis Catheter

The FDA has announced a recall of 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150 UDI 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal lumen for IV therapy, power injection of contrast media, and central venous pressure monitoring, because labeled catheter size may be incorrect.  For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176672.

Healthcare Worker Scams

The Washington State Department of Health has been notified that scam artists are calling various health professionals across the state claiming suspicious activity with their license.  Reports indicate that scammers are using department phone numbers as their own.  This appears to be part of a larger extortion scheme related to scammers posing as government officials.  This is not how WA DOH or other government or quasi-government boards, commissions, and agencies operate, and all health professionals should be skeptical of anyone making such demands.  Please be aware that WA DOH, boards, and commissions will never call you asking for your DEA number, private information, or looking for payment.  If you receive a call and want to know if there is a legitimate issue with your credential, please contact us at hsqa.csc@doh.wa.gov.  While WA DOH has issued this notice, it certainly will apply to other states as well.

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.