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:
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.
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 email@example.com. While WA DOH has issued this notice, it certainly will apply to other states as well.
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.