Medrad Inc Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051
Brand
Medrad Inc
Lot Codes / Batch Numbers
Catalog Number : AVA500HC. Lot Numbers: 0906AACL01, 0906AACL02, 1006AACL01, 1006AACL02, 1006AACL03, 1106AACL01, 1106AACL03, 1106AACL04, 1106AACL05, 1206AACL01, 1206AACL02, 1206AACL03, 0107AACL01, 0107AACL02, 0107AACL03, 0107AACL04, 0107AACL05, 0107AACL06, 0207AACL01, 0307AACL01, 0307AACL02, 0307AACL03, 0407AACL01, 0407AACL02, 0507AACL01, 0507AACL02, 0607AACL01, 0607AACL02, 0607AACL03, and 0707AACL01.
Products Sold
Catalog Number : AVA500HC. Lot Numbers: 0906AACL01, 0906AACL02, 1006AACL01, 1006AACL02, 1006AACL03, 1106AACL01, 1106AACL03, 1106AACL04, 1106AACL05, 1206AACL01, 1206AACL02, 1206AACL03, 0107AACL01, 0107AACL02, 0107AACL03, 0107AACL04, 0107AACL05, 0107AACL06, 0207AACL01, 0307AACL01, 0307AACL02, 0307AACL03, 0407AACL01, 0407AACL02, 0507AACL01, 0507AACL02, 0607AACL01, 0607AACL02, 0607AACL03, and 0707AACL01.
Medrad Inc is recalling Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog n due to Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised
Recommended Action
Per FDA guidance
The recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026