The FDA has announced a Class II recall of 212 cases of Diasol 1000225-10-DEX100 Liquid Acid Concentrate for Bicarbonate Hemodialysis, UDIs B467100225101004 and B4671000225101004, Lot PHQ03041/030920, because of mislabeling. They were distributed in California. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181559.
The FDA has announced the Class II recall of the following Baxter/Gambro HD Cartridge blood sets because of potential for tubing disconnection:
- Gambro Cartridge Blood Set Prime Line, Product Code 101025, UDI 37332414007837, 56 lots; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181127.
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, Product Code 109536, UDI 37332414085217, 4 lots; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181241.
- Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114434, UDI 47332414112395, 5 lots; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181242.
- Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114435, UDI 37332414112401, 3 lots; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181243.
The FDA has announced a Class II recall of one lot of the Bard Peripheral Vascular BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 because of a magnetic deficiency that may delay or prevent formation of a functioning fistula. For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=179704.
CDC has released a new HAN Health Alert Advisory on Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat COVID-19. The Summary includes “Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death. Clinicians and public health officials should discourage the public from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums). Clinicians should advise patients and the public that chloroquine, and the related compound hydroxychloroquine, should be used only under the supervision of a healthcare provider as prescribed medications.” Find the CDC HAN at https://emergency.cdc.gov/han/2020/han00431.asp?deliveryName=USCDC_511-DM24285.
The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions. Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401. For full details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=178095.
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:
- Product Code 107493; All Lot numbers; GTIN 07332414073718; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176496.
- Product Code 113081; All Lot numbers; GTIN 07332414105266; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176499.
- Product Code 115269; All Lot numbers; GTIN 07332414117702; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176501.
- Product Code 955542; All Lot numbers; GTIN 07332414124236; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176501.
- Product Code 6023014700; All Lot numbers; GTIN 07332414073718; see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=176502.
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.