TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used
FDA device recall Z-1305-06 · posted 2006-07-28 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting
- Action taken
- The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- NFA
- Quantity affected
- 69 kits
- Distribution
- The product was shipped to hospitals in Germany and Italy.
- Date initiated
- 2006-04-06
- Date posted
- 2006-07-28
- Date terminated
- 2006-08-10
- Location
- Exton, PA
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