Recall Z-0674-06 ยท FAD Stent, Ureteral
Cook Urological, Inc.
Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
| Date | Mar 23, 2006 (initiated Mar 1, 2006) |
| Status | Terminated |
| Reason | Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received. |
| Quantity | 1300 |
| Distribution | Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.