VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Hazard
Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
What You Should Do
Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.
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Products
- Brand
- Cordis Corporation
- UPC
- Product Code 67021055, lot X0704002
Units Affected
153 units