FDA Medical Device Recalls (openFDA)
Acist Medical Systems: AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
- Recall number
- Z-1002-04
- Recalling firm
- Acist Medical Systems
- Product
- AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
- Status
- Terminated
- Initiated
- 2004-05-19
- Posted
- 2004-07-20
- Terminated
- 2005-11-03
- Reason
- Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
- Root cause
- Other
- Action
- Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
- Quantity
- 3590 kits
- Distribution
- not on file
- Lot, serial or model codes
- Lot # 0584B
- 510(k) numbers
- ["K984231","K991103"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 3001726808
- Firm city
- Eden Prairie
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28