Recall Z-1584-05 ยท KOE Dilator, Urethral
Cook Urological, Inc.
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
| Date | Sep 24, 2005 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | Mislabeled as to size. |
| Root cause | Other |
| Action | The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit. |
| Quantity | 3 |
| Distribution | California and Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811833 | VNACE FASCIAL DILATOR SET Vance Products, Inc., Jul 10, 1981 |