Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .0
FDA device recall Z-0623-2010 · posted 2010-01-13 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- 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).
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 145 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-08-25
- Date posted
- 2010-01-13
- Date terminated
- 2010-08-11
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905) | Maxxim Medical | 2001-08-28 |