Chlorhexadine Warning

The FDA has announced a warning that rare but serious allergic reactions have been reported with widely used skin antiseptic products containing chlorhexidine gluconate.  Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years.  The FDA has asked manufacturers to add a new warning label.  For full details, including FDA recommendations for continuing use, see http://www.fda.gov/Drugs/DrugSafety/ucm530975.htm .

Recalls: Baxter Products

The FDA has announced these Class II recalls of Baxter products:

Recalls: Fresenius HD Systems

The FDA has announced a Class 2 recall of all serial numbers of the Fresenius HD Systems 2008T, 2008K, 2008K2, and 2008K@Home Series because the machines do not execute the indicated UF rate when the UF rate, goal, or time is adjusted using the up/down arrow keys and then subsequently canceled with the ESC key.  Until Fresenius issues and installs a software upgrade, all users are advised to use the numeric keys to adjust values, then use the CONFIRM key to save the values.  For full details see: 

CDC HAN on Seoul Virus

CDC has issued an HAN Health Alert on Seoul Virus, a hantavirus, which can be contracted from pet rates and can result in potentially fatal Hemorrhagic Fever with Renal Syndrome (HFRS).  The primary source of the Virus in the US is in the Midwest, but infected rats have been found in much of the US.

Seoul virus is transmitted from rats to people.  People who become infected with this virus often exhibit relatively mild or no symptoms, but some develop HFRS (https://www.cdc.gov/hantavirus/hfrs), which can result in death in approximately 1–2% of HFRS cases.  Symptoms include fever, severe headache, back and abdominal pain, chills, blurred vision, redness of the eyes, or rash.  HFRS is characterized by a prodromal phase with non-specific symptoms and can progress to hypotension, decreased urine output, and renal failure, which often resolves after a diuretic phase.  Coagulopathy and pulmonary edema are rare complications.  Laboratory findings include low platelets, elevated white blood cell counts, electrolyte abnormalities, elevated blood urea nitrogen (BUN) and creatinine, and proteinuria.  Find the HAN notice at https://emergency.cdc.gov/han/han00400.asp .

Recall: Fresenius HD Systems

The FDA has announced a Class 2 recall of all serial numbers of the Fresenius HD Systems 2008T, 2008K, 2008K2, and 2008K@Home Series because the machines do not execute the indicated UF rate when the UF rate, goal, or time is adjusted using the up/down arrow keys and then subsequently canceled with the ESC key.  Until Fresenius issues and installs a software upgrade, all users are advised to use the numeric keys to adjust values, then use the CONFIRM key to save the values.  For full details see 

Tego Recall Details

The recalled Needle-Free Connector from Tego, item #NM1000, applied only to lot number 3224799.

For item #D1000, the recalled lot numbers are 

  • 3239841 and 3239848 
  • 3244021, 3244022, and 3244023 
  • 3244558 and 3244560 
  • 3246196 
  • 3254636 
  • 3255850 
  • 3258004 
  • 3258326 and 3258327 
  • 3260656 and 3260657 
  • 3261516 and 3261517 
  • 3265973 and 3265975 
  • 3268523 
  • 3269593 and 3269594 
  • 3275465 and 3275467 
  • 3278966 and 3278967 

The manufacturer’s letter, with instructions for how to respond to the recall, is reproduced at https://s3-us-west-2.amazonaws.com/nwrn.org/files/N/TegoRecall0117.pdf .  Note that the lot numbers on the manufacturer’s letter are not in numerical order.