Recall Z-0623-2010 ยท DQX Wire, Guide, Catheter
Cordis Corporation
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.
| Date | Jan 13, 2010 (initiated Aug 25, 2009) |
| Status | Terminated |
| Reason | Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number). |
| Root cause | Process control |
| Action | 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. |
| Quantity | 145 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES Maxxim Medical, Aug 28, 2001 |