Vision Hollow Fiber Oxygenator
This recall has been terminated (originally issued April 22, 2003).
- Company
- Gish Biomedical Inc
- Recall Initiated
- March 31, 2003
- Posted
- April 22, 2003
- Terminated
- March 9, 2004
- Recall Number
- Z-0780-03
- Quantity
- 1749
- Firm Location
- Rancho Santa Margarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Two reports of leakage.
Distribution
Nationwide, Austria, Canada, Japan, Saudi Arabia
Lot / Code Info
Lot 205200
Root Cause
Other
Action Taken
The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
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