Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Hazard
Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.
What You Should Do
Remedy
All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
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Products
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
- Brand
- Cordis Neurovascular, Inc.
- UPC
- All lot numbers equal to or lower than: CAT 606051FX - LOT 13084977; CAT 606051JX - LOT 13077739; CAT 606051MX - LOT 13100828; CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978; CAT 606151MX - LOT 13090976; CAT 6062310F - LOT 13090973; CAT 6062310J - LOT 13090974; CAT 6062310M - LOT 13082015; CAT 6062510FX - LOT 13075472; CAT 6062510JX - LOT 13090975; CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT 13090979; CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972.
Units Affected
15 Lot numbers (46,452)