CDC Update to Recall of Baxter Heparin
Recall of Baxter heparin following reports of allergic-type reactions among dialysis and other patients in multiple states.
This is an update to a previous posting.
CDC is actively investigating cases of anaphylactoid, or allergic-type reactions among dialysis patients and possibly cardiac surgical patients in multiple states. Among hemodialysis patients, the reactions have been characterized by low blood pressure, nausea, hives, tachycardia and/or swelling of the eyes/lips/throat occurring within minutes of initiating their hemodialysis session. Most cases occurred between November 19, 2007 and January 16, 2008. To date, CDC is aware of approximately 114 cases from 14 states and has continued to receive additional reports of potential cases.
Many of the case-patients had received 1000 U/ml heparin from 30 ml or 10 ml vials manufactured by Baxter just prior to their reaction. However, case-patients also shared several other healthcare exposures in common and these exposures have not been ruled out as the possible cause of the reactions. On January 18, CDC became alerted to 4 cardiac surgery patients in Florida who developed severe allergic-type reactions following administration of Baxter heparin.
On January 17, in response to increased reports of adverse patient reactions following heparin administration, Baxter announced a voluntary recall of 9 lots of heparin vials. The recalled lot numbers are listed below. Although the cause of the allergic-type reactions remains under investigation, healthcare providers should immediately discontinue use of and segregate the recalled lots of heparin. The FDA Safety Alert can be found at this link: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj.
Note: This investigation and recall are unrelated to the contamination by Serratia marcescens of pre-filled heparin or saline syringes manufactured by Sierra Prefilled, Inc. (a.k.a. AM2PAT). (For information on that recall, see: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin).
Please contact Drs. David Blossom (404-639-4514, [email protected]) or Priti Patel (404-639-4273, [email protected]) to report additional cases with similar symptoms occurring during between November 1, 2007 and the present.
Baxter:
Heparin sodium Injection 1000 units/mL 10 mL vial lot #s 107054 and 117085
Heparin sodium Injection 1000 units/mL 30 mL vial lot#s 047056, 097081, 107024, 107064, 107066, 107074, and 107111