Acist Medical Systems AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Brand
Acist Medical Systems
Lot Codes / Batch Numbers
Lot # 0584B
Products Sold
Lot # 0584B
Acist Medical Systems is recalling AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. due to Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information.
Reason for Recall
As stated by FDA
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Recommended Action
Per FDA guidance
Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
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