FDA Recall
Terminated
Vision Hollow Fiber Oxygenator
Recall: Z-0780-03
·
Initiated March 31, 2003
Recall
- Recall Number
- Z-0780-03
- Event Number
- 26039
- Firm
- Gish Biomedical Inc
- FEI Number
- 2021836
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 31, 2003
- Posted
- April 22, 2003
- Terminated
- March 9, 2004
- Address
- 22942 Arroyo Vista, Rancho Santa Margarita, CA, 92688
Description
Vision Hollow Fiber Oxygenator
Reason
Two reports of leakage.
Action
The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
Distribution
Nationwide, Austria, Canada, Japan, Saudi Arabia
Quantity
1749