Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.
This recall has been terminated (originally issued January 13, 2010).
- Company
- Cordis Corporation
- Recall Initiated
- August 25, 2009
- Posted
- January 13, 2010
- Terminated
- August 11, 2010
- Recall Number
- Z-0623-2010
- Quantity
- 145 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
Distribution
Nationwide distribution.
Lot / Code Info
Lots 80000521 and 80000584
Root Cause
Process control
Action Taken
Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.
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