Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
- Company
- Thoratec Corp
- Recall Initiated
- December 16, 2002
- Posted
- January 30, 2003
- Terminated
- August 21, 2003
- Recall Number
- Z-0491-03
- Quantity
- 45 units
- Firm Location
- Pleasanton, CA
Reason for Recall
The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.
Distribution
The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.
Lot / Code Info
Lot Number: 17482
Root Cause
Other
Action Taken
On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
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