Vision Hollow Fiber Oxygenator with GBS Coating
This recall has been terminated (originally issued July 20, 2004).
- Company
- Gish Biomedical Inc
- Recall Initiated
- March 4, 2004
- Posted
- July 20, 2004
- Terminated
- January 4, 2005
- Recall Number
- Z-0730-04
- Quantity
- 950
- Firm Location
- Rancho Santa Margarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Customers reported leakage.
Distribution
NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
Lot / Code Info
Various
Root Cause
Other
Action Taken
Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.
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