ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
This recall has been terminated (originally issued October 24, 2003).
- Company
- Acist Medical Systems
- Recall Initiated
- October 2, 2003
- Posted
- October 24, 2003
- Terminated
- November 23, 2005
- Recall Number
- Z-0064-04
- Quantity
- 7120 kits
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
Distribution
Nationwide in the United States.
Lot / Code Info
Lot Numbers 0933A and 1003I
Root Cause
Other
Action Taken
The consignees were sent letters dated 10/2/03 which requested that the product be returned.
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