EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
This recall has been terminated (originally issued December 15, 2004).
- Recall Initiated
- November 19, 2004
- Posted
- December 15, 2004
- Terminated
- January 7, 2005
- Recall Number
- Z-0306-05
- Quantity
- 396 units
- Firm Location
- West Midvale, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
Distribution
AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
Lot / Code Info
Model EX24D, Lot No.: 58174875
Root Cause
Other
Action Taken
All consignees were notified by letter on 11/22/2004
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