Current Suspected Overdose Deaths in Delaware for 2024: Get Help Now!

Find school water testing results and additional resources

Attention Medicaid Participants: Eligibility Renewals Restarted April 1, 2023

Delaware.gov logo

DHSS Menu


Delaware Health Alert Network #287

December 5, 2012 8:57 am


Health Alert
VOLUNTARY NATIONWIDE RECALL OF ISOVUE (IOPAMIDOL INJECTION) PRE-FILLED POWER INJECTOR SYRINGES BY BRACCO DIAGNOSTICS, INC.

The Delaware Division of Public Health (DPH) is issuing this health alert to inform the medical community of the voluntary recall of Isovue (iopamidol injection) pre-filled power injector syringes by Bracco Diagnostics, Inc. due to the presence of visible particles in syringes.

Background

Isovue is indicated for angiography throughout the cardiovascular system. Although no reports of adverse events have been received, arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke. Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2. Distribution dates of the nine affected lots were from January 21, 2010 through May 9, 2012.

Recommendations

  1. Healthcare facilities and providers should not use these lots of Isovue PFS and quarantine the product.
  2. Refer to the FDA notification for details on recalled product lot numbers (http://www.fda.gov/Safety/Recalls/ucm329740.htm).
  3. Healthcare providers and patients are encouraged to report adverse events or side effects to the FDA MedWatch Safety Information and Adverse Event Reporting Program (www.fda.gov/MedWatch/report.htm).

Additional Information

******************

You are receiving this message because you are a registered member of the Delaware Health Alert Network. If you are not a member and would like to subscribe, please register at https://healthalertde.org

Categories of Health Alert messages:

  • Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
  • Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.





About the Department
Secretary's Letter
Secretary Bio
Newsroom
State Jobs
Calendar
Delaware Health Care Commission
DHSS Administration Contact
Federal COVID Funding Dashboard

Publications & Reports
Aging and Physical Disabilities
Child Support Services
Social Services
Health Care Quality
Office of the Secretary - Administration
Medicaid & Medical Assistance
Public Health

Developmental Disabilities Services
Substance Abuse & Mental Health
Visually Impaired
Councils and Committees
Trauma Informed
CostAware
Volunteer Delaware
FOIA Request Form



+