Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace,
FDA device recall Z-1912-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Vascutek, Ltd.
- Reason for recall
- Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- Action taken
- On 5/15/2015, Vascutek issued a URGENT FIELD SAFETY NOTICE to their consignee informing them of the corrective action of the affected product. The information included details of the affected devices, including potential risks and actions to be taken by medical staff and distributors.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MAL
- Quantity affected
- 12
- Distribution
- Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
- Date initiated
- 2015-05-15
- Date posted
- 2015-06-26
- Date terminated
- 2015-10-20
- Location
- Inchinnan, United Kingdom
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