Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 0
FDA device recall Z-1584-05 · posted 2005-09-24 · Terminated
Recall details
- Recalling firm
- Cook Urological, Inc.
- Reason for recall
- Mislabeled as to size.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOE
- Quantity affected
- 3
- Distribution
- California and Florida.
- Date initiated
- 2005-08-01
- Date posted
- 2005-09-24
- Date terminated
- 2005-10-26
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VNACE FASCIAL DILATOR SET (K811833) | Vance Products, Inc. | 1981-07-10 |